Radiation Therapists Pathway

Clinical research is a fundamental component of cancer care, providing new and improved approaches to the management of this broad range of diseases. Clinical research may focus on a range of areas, including diagnosis, treatment, follow–up and psychosocial care.

People working in clinical research come from a range of backgrounds – both clinical and non-clinical – and may work in a variety of settings, including hospitals, academic institutions and industry. Roles may be part–time or full–time. Key roles include:

Find out how some Australian professionals have developed their careers in these different settings. Your professional development needs will vary depending on your background and the role you are undertaking. Professional development opportunities related to clinical research are available through a range of avenues, including workplace–based learning, self–directed learning, workshops and seminars, short courses, professional networks, conferences and postgraduate qualifications. If you work in a large unit, you may have access to formal training programs through your place of work. If you are in a smaller unit or you are a single coordinator in a hospital setting, you may need to source activities outside your organisation.

If you are new to clinical research, you will probably want to start with activities that will provide you with basic information about research processes, guidelines and clinical research terminology.

Depending on your workplace, you may have access to a formal training program or you may need to identify and meet many or all of your own training needs.

Tips from Clinical Research Professionals
Many people move into a career in clinical research after working in other areas such as nursing, allied health, science- or laboratory-based roles or administration. It may be difficult at first to find a role that you are qualified for or to decide which research role will best suit you. However, making your interest in research known to colleagues and those already working in the area can be an important first step. Talk to people involved in research about what’s involved and think about areas for development that would help you in a research role.

"I applied for a job as a CNC in research but I wasn’t really qualified at that time. However, the doctor remembered me and when another role became available, he suggested that I apply for it."
(Junie, Clinical Nurse Consultant – Clinical Trials, NSW)

"Cancer research can be anything from working in a laboratory looking down a microscope to writing policies or protocols, working in an office for an organisation like TROG [Trans-Tasman Radiation Oncology Group] or ANZBCTG [Australia New Zealand Breast Cancer Trials Group], or you could be working directly with patients in a hospital inpatient or outpatient setting. I’d suggest doing some networking and finding out what types of research jobs are out there."
(Tammy, Study Coordinator and Research Unit Supervisor – Radiation Oncology, WA)

"If you really want to get into clinical research, it’s important to get some sort of exposure within the hospital system to clinical trials. Get an idea of the basics. Even if it’s only 6 months or so of data entry. If you go in without that, it can be hard."
(Jacqui, Senior Clinical Research Associate, NSW)

"If we are looking for staff and are going to advertise and I have a list of people who have approached me in the past, I give them a call and ask them to come in and meet us and sit with us for half a day, just to make sure this is something they want to apply for."
(Tammy, Study Coordinator and Research Unit Supervisor – Radiation Oncology, WA)

"Because I’d had some experience it was a great opportunity for me to put my hand up and apply for the position"
(Jacqui, Senior Clinical Research Associate, NSW)
When you start to work in clinical research, there are various guidelines on research conduct and processes and ethics that you should be aware of. Essential areas of knowledge include:
  • International Standards of Good Clinical Practice as outlined in The Australian Clinical Trial Handbook
    http://www.tga.gov.au/ct/cthandbook.htm
    Simple, practical guide to the conduct of clinical trials to International Standards of Good Clinical Practice (GCP) in the Australian context developed by the Therapeutic Goods Administration
  • National Statement on Ethical Conduct in Human Research
    http://www.nhmrc.gov.au/publications/synopses/_files/e72.pdf
    National guideline to promote ethically good human research in Australia.
  • World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
    http://www.wma.net/e/policy/b3.htm

"You need to have a basic understanding of research and things like Good Clinical Practice and the National Statement [on Ethical Conduct in Human Research]. It helps you understand from the start why you have to do things in certain ways."
(Junie, Clinical Nurse Consultant – Clinical Trials, NSW)

"The ethics and non-clinical aspects of clinical trials is something you have to learn, but you can learn it pretty quickly on the job"
(Adam, Research Unit Coordinator, QLD)
In addition to cancer expertise, it is important to have a good understanding of medical, clinical trial, and clinical research terminology. Ask colleagues what sources of information they have found helpful. Good introductory websites include:
Click here to access other useful links.

"I started out with a basic medical terminology course. And then through my own self-directed activities (reading and asking questions), I grew my knowledge. But I wish I’d had some opportunity earlier to build on that even more with some kind of study component."
(Vendra, Log Books Manager and Bi-National Colorectal Cancer Project Manager, RACS, SA)

"Coming from a health information management background and working on the Cancer Registry, I knew all the medical terminology, in particular all the numbers and codes… but the other side, for example the ethics requirements, regulatory affairs, good clinical practice wasn’t included that much. I picked up bits and pieces of that at courses such as the introductory courses to clinical trials run by the NHMRC [Clinical Trial Centre], as well as through individual trials, reading quite a few protocols… there was quite a learning curve there!"
(Adam, Research Unit Coordinator, QLD)

"If you’re new to an area, I’d suggest you don’t start by reading journal articles – they’re usually too focused and specialised. Find some good text books and start with the introductory chapters to get a basic understanding. Professional societies and interest groups often have lists of useful information for beginners."
(Madeleine, Director of the Quality of Life Office, Psycho-oncology Cooperative Research Group NSW)

"Once you’ve read half a dozen protocols front to back, you get quite a good sense of what’s involved – for me that worked because I’m that sort of person."
(Adam, Research Unit Coordinator, QLD)

"Clinical skills or medical terminology skills: if you understand the patients and the treatments, that is a major advantage."
(Adam, Research Unit Coordinator, QLD)

"I felt very lucky coming into this role with an oncology nursing background because much of it was very much second nature. I didn’t need to worry about things like how to read medical records. But if you’re coming from a non-health background there can be quite a big learning curve in terms of how hospitals work, medical records, that sort of thing."
(Jacqui, Senior Clinical Research Associate, NSW)
Attending workshops and seminars can give you an insight into research topics and processes and provide the opportunity to meet other people in research roles. Events may be available through a range of avenues including professional groups and societies, local institutions and commercial groups. Ask colleagues about local talks being given in your hospital or local area.

Reviews of education and training available for cancer research professionals undertaken by ARCs and COSA may help you find courses to suit your needs.

For more information, click here.

"Find someone who can direct you to good quality training and good quality resources – find them through professional organisations or through your workplace."
(Adam, Research Unit Coordinator, QLD)

"The Managers within Cancer Trials NSW were very supportive. The Cancer Council NSW got all the new study coordinators together and we did some basic training on things like ICH GCP and the studies we’d be working on."
(Jacqui, Senior Clinical Research Associate, NSW)

"Often workshops are offered before or after conferences. I always do two half-day workshops because they’re such a great opportunity to learn from leaders in the field."
(Madeleine, Director of the Quality of Life Office, Psycho-oncology Cooperative Research Group NSW)

"Approach ARCS – the CRA1 course can put you in good stead and show that you’re interested in a role in clinical trials."
(Junie, Clinical Nurse Consultant – Clinical Trials, NSW)

"You need to have a basic understanding of research and things like Good Clinical Practice and the National Statement [on Ethical Conduct in Human Research]. It helps you understand from the start why you have to do things in certain ways."
(Jacqui, Senior Clinical Research Associate, NSW)

When you take on a clinical research role, it can sometimes be difficult to manage the new tasks at the same time as managing your existing role. This can be a particular challenge if the research role is a part-time position. It’s important not to take on too much too quickly. Talk to others and try to define what falls within your role and what could be delegated to others. Project management and negotiation skills are key skills to develop!

Some training may be available within your organisation. For other skills, you may consider doing an external course. Areas to consider include:
  • computer/IT skills
  • organisational skills
  • time management skills (includes managing the scope of the role and delegation of tasks and responsibilities outside this scope)
  • negotiation skills (essential at all levels for building positive relationships between research sites and sponsors
  • project management skills.
For information about to access courses in these areas, click here.

"It’s important to have a good IT grounding – database management and all that that entails."
(Vendra, Log Books Manager and Bi-National Colorectal Cancer Project Manager, RACS, SA)

"When you’re first starting, it’s important to learn project coordination skills like organisation and time management. And you need to be computer literate. You might need to look for courses outside your organisation and it can be expensive, but they’re important skills to have."
(Junie, Clinical Nurse Consultant – Clinical Trials, NSW)

"People need to come to us with a thorough knowledge and understanding of medical terminology and procedures. They also need to have excellent communication skills and an eye for detail and be able to organise and prioritise their work."
(Tammy, Study Coordinator and Research Unit Supervisor – Radiation Oncology, WA)

"Industry is a very different environment – you need to be aware of how companies work and that you’re working for the company not for the hospital. That was a big learning curve for me. The company does new hire training about how the company works and how you communicate externally. They’re important things to be aware of."
(Jacqui, Senior Clinical Research Associate, NSW)
Involvement in local, state-based, national or international networks or special interest groups can be a valuable source of information, ongoing learning and support. Ask colleagues about local groups.

For more information about national and international groups, click here.

"Get involved in some of the groups as soon as possible and collaborate with peers... find someone to buddy-up with for a while."
(Adam, Research Unit Coordinator, QLD)

"Being part of networks means you receive email news alerts about opportunities. We have a research governance unit and research development office within the hospital – they send out newsletters of what’s happening in research professional development opportunities."
(Tammy, Study Coordinator and Research Unit Supervisor – Radiation Oncology, WA)
A mentor can be a great source of advice and support. Click here for tips on finding a mentor.

"I really think a mentor is a valuable thing to have. I try to mentor some people I know."
(Adam, Research Unit Coordinator, QLD)

"I think that the professional organisations and networks are happy to be contacted and can be there to mentor people. For example, I get contacted through AHRDMA [Australasian Heath and Research Data Managers Association]."
(Adam, Research Unit Coordinator, QLD)

"I drew on the experience of my colleague who had been working in cancer-specific clinical trials for 15–20 years, so I guess I had a mentor on the job. I was quite lucky. …reiterating the principles of data management and good clinical research practice... and having someone there to answer any questions I had on a daily basis."
(Tammy, Study Coordinator and Research Unit Supervisor – Radiation Oncology, WA)

"I’ve had a lot of support – from project managers. I would much rather ask a question than go and do something that’s incorrect. I’ve been a mentor to people and I always say, ‘even if it’s a silly question please ask’ because there’s nothing worse than doing something the wrong way because you were too scared to ask and you didn’t want to seem like an idiot."
(Jacqui, Senior Clinical Research Associate, NSW)
Whatever path you decide on, it is important to be proactive, seek professional development opportunities and be creative in approaches to your learning. Ask others what they have found helpful, look for opportunities outside your own organisation and learn from the people who inspire you. You may need to look for funding to undertake particular professional development initiatives. Click here for more information about funding opportunities.

"I applied for a lot of travel grants and scholarships in the early days. Once you’re more established you may not need that sort of support but early on it’s a good, pro-active way to demonstrate your enthusiasm and commitment to an employer."
(Madeleine, Director of the Quality of Life Office, Psycho-oncology Cooperative Research Group NSW)

"Enthusiasm and showing interest is what makes the biggest difference..."
(Adam, Research Unit Coordinator, QLD)

"I’ve always been lucky and have had supportive bosses who are willing to support my professional development. That’s not necessarily something you have that much control over, but I think if you show enthusiasm for what you’re doing and set high standards for your work, employers will often support you."
(Madeleine, Director of the Quality of Life Office, Psycho-oncology Cooperative Research Group NSW)

"Enthusiasm is important – you need to put a bit of energy into this stuff – it doesn’t just come automatically."
(Jacqui, Senior Clinical Research Associate, NSW)

If you are considering taking on a dedicated clinical research role, whether in the health system or in industry, you may want to consider professional development activities that will provide you with more detailed knowledge about clinical trials/research, or about the therapeutic area you will be working in. This may involve attending start-up meetings and conferences, studying for a qualification, getting more involved in professional networks and groups, and pursuing other opportunities to grow your knowledge and skills.

Clinical research is an area that changes frequently. It is important to seek and take advantage of all opportunities as they arise. Talk with other clinical research professionals working in the cancer area, attend conferences, and seek opportunities within or outside your current workplace. Identify the areas in which you need additional skills or experience and seek opportunities to fill any identified gaps. Build your experience with guidance from more experienced clinical research professionals.

"Soon after I arrived as data manager, staff left and the thing that was most urgent was the actual clinical trials requirement, so I got pushed into that and found I really enjoyed it."
(Adam, Research Unit Coordinator, QLD)

"With clinical research, you’re always at the cutting edge of things. Everything is new – so you don’t become stale. And the complexity of the trials means that it keeps you interested as you try and work out how best to get things done. There are trials involving new drugs or different stages of cancer or there are new processes to learn about. There’s always a new challenge."
(Junie, Clinical Nurse Consultant – Clinical Trials, NSW)

"...you’re in a new role and learning new skills but at the same time you have to grow with that role and if there are deficiencies, try and recognise what they are and seek out ways to address them."
(Vendra, Log Books Manager and Bi-National Colorectal Cancer Project Manager, RACS, SA)

"When I first started in the industry position it was a pretty autonomous role. So my peers were of great help. I had a lot of on-the-job training. There was monthly training through the company and I did some external courses when I first started. The company also offers therapeutic area training – so if you don’t have a health background you can go and do a preceptorship which is very helpful in giving you a feel for how patients are seen through their journey."
(Jacqui, Senior Clinical Research Associate, NSW)
Involvement in local, state-based, national or international networks or special interest groups can be a valuable source of information and ongoing learning. At a national level, organisations such as the COSA Clinical Research Professionals Group and Australasian Health and Research Data Managers Association provide opportunities for networking with others.

COSA’s 13 Australasian cancer cooperative trials groups also have strong networks, opportunities for involvement with committees, and professional development opportunities (including mentoring). Ask colleagues about local interest groups and networks that may be relevant for you. Becoming actively involved in networks and organisations provides additional opportunities for learning and networking.

Learning from online discussion groups is an advantage of special interest groups

For more information about national and international groups, click here.

"For most people, communicating and networking with people in the industry – whether they’re in the same trial or the same city – it really, really makes a difference."
(Adam, Research Unit Coordinator, QLD)

"Good communication with colleagues is helpful. I’ve been involved with COSA’s Clinical Research Professionals Group for quite some time. This year I’m the South Australian convenor for AHRDMA."
(Vendra, Log Books Manager and Bi-National Colorectal Cancer Project Manager, RACS, SA)

"Some cooperative trial groups have a specific forum for the coordinators. You get to keep up with what’s new and they’re really interesting. And you’re there with a whole lot of people who are in the same boat as you."
(Junie, Clinical Nurse Consultant – Clinical Trials, NSW)

"AHRDMA provides us with updates, newsletters and website access… being involved in AHRDMA has helped me."
(Tammy, Study Coordinator and Research Unit Supervisor – Radiation Oncology, WA)

"I encourage people to attend relevant cooperative clinical trial group meetings because it’s crucial that they’re kept in the loop."
(Adam, Research Unit Coordinator, QLD)

"TROG [Trans-Tasman Radiation Oncology Group] provides a wonderful network of data managers and coordinators who work specifically in radiation therapy."
(Tammy, Study Coordinator and Research Unit Supervisor – Radiation Oncology, WA)

"Cancer-site-specific professional organisations (such as ANZBCTG [Australia New Zealand Breast Cancer Trials Group]) really help with networking and ongoing development of data managers, because if you’ve ever got a question, you’ve got a huge range of people you can ask for help."
(Tammy, Study Coordinator and Research Unit Supervisor – Radiation Oncology, WA)

"The Cancer Councils provide all sorts of support – travel, training and research support. You really need to be tapped in to what they can offer."
(Madeleine, Director of the Quality of Life Office, Psycho-oncology Cooperative Research Group NSW)
For any clinical trial, the sponsor will usually provide a contact such as a Study Coordinator or Clinical Research Associate to assist with questions and ensure quality control.

Learning from online discussion groups is an advantage of special interest groups

For more information about national and international groups, click here.

"The study coordinators are very good. You can send them an email if you’ve got a question. Even though you may be by yourself at the site, you’ve always got that contact. So we talk to them quite often."
(Junie, Clinical Nurse Consultant – Clinical Trials, NSW)

"Go to the trial initiation meetings that are usually required for trials, or to the study groups… immerse yourself in it, make contact with all the people you should, and there’s an educational component - you really learn a lot."
(Adam, Research Unit Coordinator, QLD)

"Networking really helps, especially in Western Australia which has a fairly small metropolitan area. We do tend to network between different research units within the hospital or between other public or private hospitals."
(Tammy, Study Coordinator and Research Unit Supervisor – Radiation Oncology, WA)

"A number of the studies we run are national studies and they are usually coordinated by a head office... just with the number of other hospitals that collaborate, you get to know who other data managers are."
(Tammy, Study Coordinator and Research Unit Supervisor – Radiation Oncology, WA)

"Networking makes a huge difference – if you know someone who has some information that could possibly help you, or you think that you could possibly help them – people’s lives are a lot easier."
(Adam, Research Unit Coordinator, QLD)
Attendance at relevant state-based, national or international conferences or scientific meetings can be helpful for building both knowledge and networks. For conference listings, click here.

"For me attending conferences has been the key annual professional development activity that has assisted me with protocol design and implementation – the real scientific side of my job. I’m usually sent to a breast conference, sometimes a general cancer one, once a year."
(Tammy, Study Coordinator and Research Unit Supervisor – Radiation Oncology, WA)

"Some cooperative trial groups have a specific forum for the coordinators. You get to keep up with what’s new and they’re really interesting. And you’re there with a whole lot of people who are in the same boat as you."
(Junie, Clinical Nurse Consultant – Clinical Trials, NSW)

"For anyone wanting to work in cancer clinical research in Australia, the COSA conference is absolutely essential. COSA brings together all the different interest groups and professional groups as well as other stakeholders, including consumers – it’s multidisciplinary in the broadest sense of the word."
(Madeleine, Director of the Quality of Life Office, Psycho-oncology Cooperative Research Group NSW)

"In the public system, it was hard to get to conferences because you’d have to apply a long time in advance. A lot of companies do put on training days, so I’d often apply to go to those. I was able to do things. The limiting factors were getting funding to go to conferences or do courses, having time to go, and whether there were staff to cover you while you were away."
(Jacqui, Senior Clinical Research Associate, NSW)
Start-up meetings organised by trial sponsors are a great opportunity to learn about new trials, details of the protocol, and processes to be followed. They can also be great networking events, providing the opportunity to meet other research professionals as well as the trial sponsor.
  • understanding cancer and how it is treated
  • preparing data sets and statistical analysis
  • understanding clinical research practice guidelines
  • data management and IT skills
  • project management skills.
Belonging to networks and groups can help keep you informed of upcoming workshops and courses.

Reviews of education and training available for cancer research professionals undertaken by ARCs and COSA may help you find courses to suit your needs.

For more information about workshops and courses, click here.

"While it’s good to be in a role that is new and offers growth, keep an eye on the gap between what you know in that role and the skills that could assist you in moving forward or building on your existing skills. Because that’s the only way you can go forward."
(Vendra, Log Books Manager and Bi-National Colorectal Cancer Project Manager, RACS, SA)

"It would be useful to have a refresher on things like Good Clinical Practice every couple of years. Things can change and the guidelines can sometimes be open to interpretation so an update would be useful."
(Junie, Clinical Nurse Consultant – Clinical Trials, NSW)

"I’m involved in disseminating information for a national group, AHRDMA [Australasian Health and Research Data Managers Association], so I found out about courses and conferences and things pretty early on, and I try to send that out to our members, my staff and anyone else I’m aware of."
(Adam, Research Unit Coordinator, QLD)

"A medical record reading course may be an option [for people starting in an industry role] if you haven’t done that before."
(Jacqui, Senior Clinical Research Associate, NSW)
In addition to your cancer skills and knowledge, you may also identify other general skills that will help you in your role. Training may include communication skills training or presentation skills training. Communication or negotiation skills training can help both in your relationship with other team members as well as with your relationship with patients. If you are involved in recruiting patients to research studies, it is important that you strike the right balance between informing patients about what’s involved without placing undue pressure on them to take part. For more information, click here.

"It was difficult (to understand that I would be accepted onto a postgraduate program) because I didn’t have an undergraduate degree. I sent them a letter outlining my experience and my resume and they accepted me into the (health management) program."
(Vendra, Log Books Manager and Bi-National Colorectal Cancer Project Manager, RACS, SA)

"I’d already been doing trials for a while before I did the Masters so it’s hard to say how much it helped me. But I know others who started doing it before doing the job and they say it helps them appreciate why the sponsors ask you to do what you have to do."
(Junie, Clinical Nurse Consultant – Clinical Trials, NSW)
While rewarding, working in cancer care can also be challenging emotionally and psychologically. There are many strategies you can use to help you deal with the emotional and psychological stress of working in cancer care and to help avoid burn-out.

An important aspect of training for clinical trials professionals working in cancer care is self-care. To access a list of self-care resources, click here.

If you are working at or considering moving into an advanced role in the clinical trial setting, your professional development needs will be more specific.

Tips from clinical trials professionals
As you build your skills, you may have the opportunity to take a more active role in planning research activities and applying for grants. As part of your role you may identify gaps in knowledge and be in a position to develop research projects aimed at addressing these gaps. You could lead your own project at a local, regional, state, national or international level.

"I’ve recently started getting more involved in applying for grants so that’s a new area to learn about."
(Junie, Clinical Nurse Consultant – Clinical Trials, NSW)
In addition to joining a society or organisation, you may find it valuable to join a state-based or national committee as a way of strengthening your links and learning about committee working and processes.

"I saw an advert asking for expressions of interest to sit on a cancer-related ethics committee. I saw that as a great learning opportunity and I joined the committee for 2 years. I learned a tremendous amount."
(Madeleine, Director of the Quality of Life Office, Psycho-oncology Cooperative Research Group NSW)
Giving presentations at national and international conferences can help you learn while also sharing knowledge with others. Being involved in the organising committees for conferences can be rewarding and can help you develop new networks. For conference listings, click here.

"Being involved in a conference organising committee is very valuable. It’s a tremendous amount of work but when you’re at a mid-career stage you have time to do it, and it can be a wonderful learning experience and a contribution of service to your community. It can also help your science – by getting to know the leaders in a field, you get to see how they think and how they approach things and you often get to find out things long before they’re published."
(Madeleine, Director of the Quality of Life Office, Psycho-oncology Cooperative Research Group NSW)
You may decide to undertake a research-based qualification such as a Masters in Public Health, Pharmaceutical development, Business Administration or PhD.

For more information, click here.

As you take on more senior and specific roles in clinical research, you may find yourself becoming more focused on a particular therapeutic area or a particular aspect of the trials process. Staying aware of broader issues in cancer care outside your area of focus can be helpful in providing new ideas and in keeping options open for future areas of development.

"Once you move out of the clinical side of things, you can lose touch with what current practice is, the [Cancer Institute NSW] Ci-Scat site is fabulous and I often go onto the site to see what’s currently being used. I think it’s a fabulous site and is a good one for learning because it has therapeutic areas, symptoms, side effects and all those kind of things."
(Jacqui, Senior Clinical Research Associate, NSW)
In addition to your cancer and research skills and knowledge, as you take on more senior roles you may need additional management or leadership skills that will help you in your role. For more information, click here

"The current role entails not only registry and audit work but also a management role so I’ve had to develop skills in that area as well."
(Vendra, Log Books Manager and Bi-National Colorectal Cancer Project Manager, RACS, SA)

"In Australia there are very few standards or protocols involved with registries work and little external learning available, although some work has just commenced in this area. It would be good to see something like the US model come to Australia, so people have the opportunity to be supported, be provided with education and the ability to develop standards so that we can compare ourselves internationally."
(Vendra, Log Books Manager and Bi-National Colorectal Cancer Project Manager, RACS, SA)
Whatever your field of research, publishing the results is an important way of informing others about what you have been doing. Publications can be time-consuming but are an important aspect of developing a research career.

"Getting papers published is something we all struggle with – but it’s really important so we need to keep trying."
(Madeleine, Director of the Quality of Life Office, Psycho-oncology Cooperative Research Group NSW)

Find out what clinical trials professionals do in cancer care, how they have built their careers in cancer care and what professional development activities they have found useful:

Role Research Unit Coordinator for the Division of Cancer Services at Princess Alexandra Hospital, Brisbane, with responsibilities for:
  • managing 14 staff involved in clinical trial coordination and maintaining a range of clinical databases
  • research management activities undertaken by the division.
"I like clinical trials… after first having patient contact, I was blown away by it… it’s a great area to work in..."

"In cancer, there is huge variety. The types of trials we’re dealing with can be from the home grown ones or the little lab studies or the phase zero type work right up to the big phase III research with some pretty big companies involved, where you see the progress of the study throughout the world, the patients are interested, and its getting close to possibly producing a product that’s going to do some good."
Links Metastatic melanoma trials

Haematology trials

Increasing awareness of and participation in clinical trials

Pathway
  • As a new graduate in Health Information Management, worked at the Queensland Cancer Registry
  • Data manager position at the Princess Alexandra Hospital involving maintaining the hospital-based cancer registry, clinical classification of hospital admissions and coordination of clinical trials
  • Five years experience at the Queensland Cancer Fund
  • Returned to the Princess Alexandra Hospital in supervisory position
Training and courses
  • Undergraduate degree in Health Information Management
  • Further IT training at university
  • Project management training
  • Additional courses as required
Groups and networks
  • AHRDMA (Australasian Health and Research Data Managers Association) – currently Business Secretary
  • COSA (Clinical Oncological Society of Australia)
  • ACRP (Association of Clinical Research Professionals) – international organisation
What helps?
  • Understanding medical terminology
  • Reading trial protocols
  • Attending courses
  • Having broad experience in database management, research management and population-based research outside of the clinical trials arena
  • Participating in professional groups and disease-related study groups
  • Accepting or seeking all opportunities to expand your role, even if not initially relevant to cancer clinical trials
  • Communicating and networking
  • Having a mentor
  • Attending conferences
"I went to a clinical research excellence conference a little while ago, attended by organisations by ACRP and ARCS… it was a really good conference, with a lot of clinician involvement as well as clinical research people..."
Role Clinical Nurse Consultant – Clinical Trials
Nepean Cancer Care Centre

Role involves coordination of all aspects of clinical trials at the Centre, including ethics submission, start-up activities, patient recruitment and consent, study-specific tasks, follow-up and archiving
Trials cover all cancer streams, may be sponsored by pharmaceutical companies or cooperative clinical trial groups and may be national or international Role involves liaison with trial sponsors, doctors, other research staff and data managers, and other relevant departments, eg chemotherapy, radiology

Provides guidance to other research staff within the Centre

"What’s so brilliant about clinical research is that it uses your nursing skills as well as giving you the opportunity to learn something different. It’s really kept my interest."
Pathway
  • 30 years experience in nursing
  • 15–20 years experience in cancer care
  • 8 years experience in clinical research
I started getting more and more interested when people talked about studies and I thought, ‘I could do this’.
Training and courses
  • Registered Nurse
  • BA with Psychology Major
  • Graduate Certificate in Clinical Trials and Data Management
  • On-the-job training
"It was a very steep learning curve for me. It’s a very autonomous job. Even though you work in a group, if you work on a trial by yourself, you really are working by yourself. So you have to be able to get along with and know everybody – the day ward, the chemotherapy nurses, the radiographers, the radiology department. But at the same time you have to be autonomous and self-motivated. And I learned that on the job"
Groups and networks
  • Member of a number of nursing groups
  • Member of the Australasian Health and Research Data Managers Association (AHRDMA)
What helps?
  • Networking with colleagues
    "I find I always want to know better ways to organise things. I’m always picking peoples’ brains."
  • Attending start-up meetings and cooperative trial group scientific meetings
    "I really find the start-up meetings and cooperative trial group scientific meetings invaluable. Not just from learning about the trials, but because of the opportunity to network. It’s one of the best things you can do. You exchange a lot of information and get to know how other people are doing things."
  • Useful websites:
  • Other skills:
"You need to be organised and have an idea about project management and time management." "Having an understanding about research, protocols and what an endpoint is can help you understand why you’re doing what you’re doing."
Role Cancer Australia Chair in Cancer Quality of Life

Director of the Quality of Life Office, Psycho-oncology Cooperative Research Group http://www.pocog.org.au/

Full-time role, covering all of Australia that involves:
  • working across the cancer clinical trials groups to encourage and foster high quality-of-life sub-studies and studies within their clinical trials
  • developing a research agenda in quality of life that explores methodological areas (eg measurement, analysis and interpretation of quality of life in cancer)
  • developing links, collaborations and networks with similar international groups
  • building capacity in Australia for the conduct of quality-of-life research.
"Australia has 13 national cancer cooperative groups. PoCoG is one of the newer groups and is fairly unique in the world as it focuses exclusively on psycho-oncology."
Pathway
  • Prior to university worked in the computer industry
  • Undergraduate degree focused on science and biology
    "I developed an interest in statistics in my honours year – because I realised that it was something that absolutely underpinned good research."
  • Roles in Forestry and Wildlife and then Fisheries
  • Biometrician’s Assistant in Fisheries for 5 years
    "I was very comfortable with computers and maths and had a very good grounding in science from my undergraduate degree – so the Biometrician’s Assistant role worked well. But it was frustrating because there were limited job opportunities available locally for career advancement."
  • First job in health was a 2-year role in an epidemiological study on sleep apnoea
  • Worked for 17 years in a range of roles at the Centre for Health Economics, Research and Evaluation (CHERE) http://www.chere.uts.edu.au/; involved in clinical research and health services research across asthma, cancer and dementia; developed a particular interest in quality-of-life research
    "They weren’t actually advertising for a statistician – they were advertising for health economists and researchers. But I phoned up and suggested they may need a statistician. So the Director gave me a year’s probationary role – and 17 years later I was still there!"
  • Moved to current role in 2008
Training and courses
  • BSC (Hons) in Environmental Ecology
  • PhD examining and comparing cancer quality of life instruments in breast cancer
  • Range of intensive courses and workshops on statistics (eg analysis of longitudinal data) and psychometrics (eg Rasch analysis)
"At the end of my PhD I was more interested than ever in quality of life so I continued to pursue that."
Groups and networks
  • Member of the International Society for Quality of Life Research http://www.isoqol.org/ (various roles including committee member, Board member, chair of conference organising committee and President)
  • Clinical Oncological Society of Australia (COSA) http://www.cosa.org.au/
  • Psycho-oncology Cooperative Research Group (PoCoG) http://www.pocog.org.au/
"Getting involved in Societies is a really good way to learn – you get to know the movers and shakers in a field. It’s been a very rewarding experience for me. I have got to meet so many people who have contributed to the field, and that’s a fantastic network to have."
What helps?
  • Being involved on committees
    "Sitting on committees is a great learning experience – you get to learn about processes, meet people and fill in gaps in your professional development while also giving something back to your community. It’s a really nice two-way process."
  • Attending conferences
    "Conferences are excellent – once a year you have a very intensive 3 days in which you can find out who’s doing what and hear about good ideas that can inspire you to tweak what you’re doing or to do new research."
  • Going to workshops and seminars "Academic groups usually have a seminar series. If you can tap into these – not only at your own institution but at other universities or institutions – it can be a great way of hearing who is doing what in bite-sized chunks."
  • Self-directed learning:
    • Start with introductory sections of relevant text books
    • Read journal articles to find out more focused and specific information
    • Use the web
    • Sign up for e-alerts from relevant organisations and societies
  • Be pro-active and always look for new opportunities
    "There’s always more to learn. Learn from the example of people you admire. Have high standards in what you do, within your time and resource constraints."
  • Be selective – choose learning opportunities that best meet your needs
"Our most precious resource is time. We may only be able to go to one or two conferences a year – so choose your conference very carefully. Make sure it’s very closely linked with your interests and what you want to learn about and the direction you want to go in your career."
Role Study Coordinator and Research Unit Supervisor within the Radiation Oncology department, Sir Charles Gairdner Hospital, Perth, WA

"I like a lot of the aspects of my role. I have a broad set of responsibilities ranging from helping with the design and implementation of clinical trial protocols, through to doing all the regulatory reporting… though to patient interaction."

"Being able to be involved in projects that are going to potentially improve the outcome for patients or improve their experience throughout their treatment for cancer – that is very rewarding… it’s something you feel is going to have a fairly big, positive impact later on down the track."
Links Breast cancer
Radiation oncology
Pathway
  • Worked part time as a research assistant as an undergraduate student,
    "I got a little taste for working in research having worked part time at the Family Medicine Research Unit in Sydney while studying… I was employed to help with some of the coding and had a role as a research assistant… I went out of my way to look for research roles when I graduated..."
  • As new graduate, worked for three years as data manager for a national prostate cancer study.
    "I helped one of the radiation oncologist consultants here implement the National Prostate Cancer Study over 20 centres across Australia – helping with ethics application processes, getting the study up and running where I needed to design data collection forms and the database to enter the data into and ensuring quality data and timely data..."
  • Then became involved in an international breast cancer and radiation oncology trial (http://www.targittrial.org/) , which she still oversees seven years later "We’re the largest recruiting centre in the world for that study, so we have a lot to share."
Training and courses
  • Currently applying to do a PhD
  • Postgraduate diploma in Public Health
  • Undergraduate degree in Health Information Management
  • NHMRC Clinical Trials Centre courses
  • Grant-writing workshops
  • Training in aspects of management
  • Additional courses as offered and as required
"The biggest thing I’ve tried to factor in my working life is to continue studying… I’ve always planned to never stagnate, to always be involved in professional development opportunities – to look out for them and to take them up when they’re offered."
Groups and networks
  • AHRDMA (Australasian Health and Research Data Managers Association)
  • TROG (Trans-Tasman Radiation Oncology Group)
  • ANZBCTG (Australia New Zealand Breast Cancer Trials Group)
What helps?
  • Having an undergraduate degree in Health Information Management
    "I drew a lot from my degree in Health Information Management when I first started working in cancer trials. It’s a fairly broad degree and gave me basic theory in all principles of disease processes, medical terminology, clinical classification, coding – all of these helped me with the scientific aspect of my work"
  • Having a mentor
  • Being aware of local professional development opportunities
  • Attending conferences, including: San Antonio Breast Cancer Symposium, European Cancer Conference, European Breast Cancer Conference, European Society of Surgical Oncology Conference
  • Attending annual scientific meetings of key groups such as TROG (Trans-Tasman Radiation Oncology Group)
  • Recognising your own weaknesses so that you can seek professional development opportunities to address them
  • Having a thorough understanding of medical terminology and procedures
Useful websites
Role Senior Clinical Research Associate with a biotechnology company

Role involves monitoring clinical trials according to ICH Good Clinical Practice and company standard operating procedures

Main focus on oncology studies and some nephrology studies
Pathway
  • Started as a Registered Nurse, specialising in oncology and haematology
  • Progressed to a Clinical Nurse Specialist in Oncology and Haematology
  • Over a period of 12 years, undertook a range of roles in the public health/hospital system, within inpatient and outpatient settings, chemotherapy administration, bone marrow/peripheral blood stem cell coordinator
  • Became a Blood Transfusion Surveillance Clinical Nurse Specialist within a public hospital blood bank. Whilst in this role undertook a part-time position within the clinical trials unit based in the same hospital for 1 year attending home visits to patients involved in clinical trials for trial-related procedures
    "I’d been involved in trials on the wards but that role gave me more exposure to the data management side of things, adverse events and the kinds of things that needed to be captured."
  • Moved to a regional NSW area and took on a role as a Clinical Nurse Specialist in an outpatient chemotherapy unit and worked part time for the Cancer Council NSW as a Regional Programs Coordinator and Project Officer
  • Undertook a 1-year position with the Cancer Council NSW as a Study Coordinator as part of their Cancer Trials NSW Program
  • Moved back to Sydney and took an entry-level Clinical Research Associate role in industry; has been with the same company for 4 years
"I pretty much put my hand up for most things. When new roles came up I thought they would be good learning opportunities. I would strongly encourage people to do that. Certainly within the public health system there are always different roles that are going to come up. I felt that it would show that I’m adaptable and open to change. It also gave me a sense of achievement and kept me interested."

"I’ve had a pretty open mind throughout my career and I’m happy with change. As a newly registered nurse, oncology and haematology seemed so daunting. But after about 3 months, it just clicked and I realised I really liked it."
Training and courses
  • Registered Nurse
  • Oncology Nursing Certificate
  • Training courses offered through employers
  • ARCS training courses
  • On-the-job training
"When I first started in the industry position it was a pretty autonomous role. So my peers were of great help. I had a lot of on-the-job training. There was monthly training through the company and I did some ARCS training when I first started. The company also offers therapeutic area training – so if you don’t have a health background you can go and do a preceptorship, which is very helpful in giving you a feel for how patients are seen through their journey."
Groups and networks
  • Member of COSA (Clinical Oncological Society of Australia) and CNSA (Cancer Nurses Society of Australia) while in nursing roles
  • Currently a member of ARCS
What helps?
  • Talking to and learning from peers and colleagues
    "I’ve had a lot of support from project managers. I would much rather ask a question than go and do something that’s incorrect. I’ve been a mentor to people and I always say, ‘even if it’s a silly question please ask’ because there’s nothing worse than doing something the wrong way because you were too scared to ask and you didn’t want to seem like an idiot."
  • Useful websites:
  • "Once you move out of the clinical side of things, you can lose touch with what current practice is, the Ci-Scat site is fabulous and I often go onto the site to see what’s currently being used. It’s a good site for learning because it provides information by therapeutic area, and lists symptoms, side effects and all those kind of things."
  • Perseverance!
    "It took me 6 months to get an industry role. Things are starting to change but it can be hard to get a role without industry experience. Don’t be disheartened. If you’re keen, stick with it. Entry level roles do come up but you may need to wait."
  • Get some experience in trials before applying for positions
    "If you really want to get into clinical research, it’s important to get some sort of exposure within the hospital system to clinical trials. Get an idea of the basics. Even if it’s only 6 months or so of data entry. If you go in without that, it can be hard."
Role Log Books Manager and Bi-National Colorectal Cancer Project Manager Royal Australasian College of Surgeons (the College)
  • Log Books Manager role involves recording surgeon’s education experiences and smaller audits within that eg specific tumour types, different procedures
  • Bi-national Colorectal Cancer Project Manager role involves rolling out the colorectal cancer audit in Australia and New Zealand (working with the Colorectal Surgical Society of Australia New Zealand, the College and BioGrid Australia)
Pathway
  • Started work in a secretarial role in health
  • Moved into the cancer area with an interest in research
  • Worked for 5 years with the clinical cancer registry in South Australia; role involved staging disease, and looking at pre- and post-diagnosis information for colorectal cancer and urological cancers
  • In current role for 18 months
"I found a niche in that particular area because I was good with things like data management and technology, and especially interested in the database side of things."
Training and courses
  • While in cancer registry role, undertook a post-graduate course at Flinders University: Graduate Certificate in Health (Health Service Management); currently working towards Graduate Diploma; course undertaken on an external basis
    "I have a family and work full time so the external course suited me. They’ve been really supportive."
    "It was difficult (to understand that I would be accepted onto a postgraduate program) because I didn’t have an undergraduate degree. I sent them a letter outlining my experience and my resume and they accepted me into the (health management) program."
    Management workshops (undertaken in current role)
  • Medical terminology workshop
  • Self-directed learning in cancer terminology and relevant registry and audit information
Groups and networks
  • Member of COSA (Clinical Research Professionals Group)
  • South Australian convenor of the Australasian Health and Research Data Managers Association (AHRDMA)
What helps? "It’s not just about technical skills. Often with these projects you’re dealing with a large number of people from all kinds of areas and there can be competing interests and agendas. So it’s really important to be able to communicate and manage those relationships because in the end you’re all working towards the same thing."

Clinical Oncological Society of Australia (COSA)
http://www.cosa.org.au//ASMEvents/OtherEvents.htm

Australasian Health and Research Data Managers Association (AHRDMA)
http://www.ahrdma.com.au/?page=events

ARCS Australia
http://www.arcs.com.au/Industry-Events.html

ASCO (the American Society of Clinical Oncology)
http://www.asco.org/ASCO/Meetings/Calendar+of+Events

ASH (American Society of Haematology)
http://www.hematology.org/calendar.cfm

EORTC (European Organisation for the Research and treatment of Cancer)
http://www.eortc.be/Seminar/InternationalConferences.htm

Association of Clinical Research Professionals (ACRP)
http://www.acrpnet.org/MainMenuCategory/Conference.aspx

This section lists relevant postgraduate qualifications. A range of other postgraduate qualifications, including PhDs, are also available that may be relevant for you. Talk to colleagues or professional bodies for more information.

Relevant qualifications may include a Graduate Diploma, Graduate Certificate or Masters course. Graduate certificate courses are typically 1-year courses and represent the baseline entry level programs for a Masters qualification. Graduate diploma qualifications are typically shorter than Masters programs and often have more flexible entry criteria. Some institutions offer part-time and distance learning options. A Masters qualification is typically 2 years in duration although many institutions offer part-time and distance education options.

Options may include one of the following topics:

  • Health Science (Clinical Data Management)
  • Clinical Trials Management
  • Biostatistics
  • Nursing Research
  • Clinical Epidemiology

It is worth reviewing course details on university websites for information about course options and requirements.

Biostatistics Collaboration of Australia
http://www.bca.edu.au/index.html

Postgraduate program in biostatistics, delivered entirely by distance by a consortium of biostatistical experts from around Australia

SHORT COURSES

Short courses are available through a range of public and private providers.

NHMRC Clinical Trials Centre
http://www.ctc.usyd.edu.au/education/education.htm
One-day and two-day courses in design, conduct, analysis and evaluation of clinical trials for clinical trials personnel and people who have an interest in clinical trials research.

Monash University
http://www.med.monash.edu.au/epidemiology/shortcrs/past-courses.html
Short courses offered on a range of subjects.

ARCS
https://arcs.eventsinteractive.com/cm.esp?id=3&pageid=EVSEARCH&eiscript=&userID=
Range of courses offered for individuals working in the clinical research industry.

Nucleus Network
http://www.nucleusnetwork.com.au/page.aspx?54
Web-based and face-to-face education on a range of clinical research topics.

Queensland Clinical Trials Centre
http://www.uq.edu.au/qctc/index.html?page=22588
Offers two short courses developed in collaboration with the NHMRC Clinical Trials Centre

Caledonian Clinical Training
http://www.ahrdma.com.au/?page=resources
Courses designed for study coordinators

Association of Clinical Research Professionals
http://www.acrpnet.org/MainMenuCategory/Education.aspx
International group offering online education on a range of clinical research topics.

A variety of workshops and seminars are available. For industry-sponsored trials, investigator workshops and meetings are provided by the trial sponsor. Many of the cancer clinical trials study groups and professional organisations also run short courses and seminars.

Seminars are also available through local health care institutions and university-based groups. Ask colleagues for more information.

Queensland Clinical Trials Network
http://www.qctn.com.au/ProductsServices/TrainingSeminars/tabid/227/Default.aspx
Educational initiatives and courses for clinical trials professionals.

ACCORD conference
http://www.acordworkshop.org.au/
Biannual 1-week intensive training workshop focused on the essentials of clinical trials design for cancer researchers in all oncology subspecialties from Australia and the Asia-Pacific region.

You may find it helpful to undertake training in a range of project management or general skills:

  • courses on computing or information technology may be available through local area health services or your institution
  • courses on statistics may be offered through TAFE or university settings
  • information about project management and time management skills training is available through groups such as AHRDMA and ARCs as well as through private training organisations; be aware that while they may be useful, general project management courses will not be specific to the needs of clinical research
  • communication skills training courses are offered through a range of organisations including:
  • negotiation skills and presentation skills training courses are available through a range of private providers – ask others what they have found helpful; some people have reported that they found the Toastmasters courses valuable in building their confidence http://www.toastmasters.org.au/
  • tips on communicating with the media are available through the Australian Science Media Centre http://www.aussmc.org/scientists.php
  • courses on leadership and mentoring may be available through your workplace or through TAFE or university settings.

Cancer Learning list of Self-care resources: Work/Life Balance

EdCaN learning resources
Case studies: http://www.cancerlearning.gov.au/edcan_resources/#/xml/module_3/casestudies/

Supporting modules:

CI-SCaT (Cancer Institute NSW Standard Cancer Treatments)
https://www.treatment.cancerinstitute.org.au/cancerinstitute/cancerinstituteDADAServlet?sid=445276CIS&page=0BENPC&gen=0

Cancer Institute NSW – presentations used in training for trials nurses and data managers http://www.cancerinstitute.org.au/cancer_inst/research/pdf/2007-10-13_clinical-trials-presentation-for-workshop.pdf

Health Insite
http://www.healthinsite.gov.au/topics/Clinical_Trials
Series of links to information sources regarding clinical trials

Medicines Australia
http://www.medicinesaustralia.com.au/pages/index.asp
Australian association representing innovative medicines industry in Australia. Website includes a section on clinical trials http://www.medicinesaustralia.com.au/pages/page39.asp as well as the pharmaceutical industry code of conduct http://www.medicinesaustralia.com.au/pages/page5.asp

Victorian Managed Insurance Authority
http://www.vmia.vic.gov.au/display.asp?entityid=3023
Guidelines and clinical trial agreements developed to support clinical research in Victoria.

ICH guidelines
http://www.ich.org/cache/compo/276-254-1.html
Internationally developed and recognised guidelines across all aspects of clinical trials, including Quality, Safety, Efficacy and Multidisciplinary topics. Includes a guideline on Good Clinical Practice to guide the conduct of clinical research - http://www.ich.org/LOB/media/MEDIA482.pdf

National Cancer Institute
http://www.cancer.gov/
USA based website – includes information for consumers and health professionals about different cancers and treatment options, including complementary medicines.

British Columbia Cancer Agency
http://www.bccancer.bc.ca/default.htm
Canadian based website – includes information for consumers and health professionals, including management protocols by disease state.

National Comprehensive Cancer Network
http://www.nccn.org/
USA based website that includes clinical guidelines for cancer treatment.

Multinational Association for the Supportive Care in Cancer
http://www.mascc.org/content/6.html
International multidisciplinary website includes links to clinical practice guidelines in supportive care.

COSA and Cooperative Groups Enabling Grant Project http://www.cosa.org.au//Groups/Enabling.htm

NHMRC Grants
http://www.nhmrc.gov.au/grants/types/list.htm
Broad range of funding opportunities for all areas of research relevant to human health and medical research.

CANCER COUNCILS

State and Territory Cancer Councils offer a range of grants, fellowships and scholarships to support clinical research

Cancer Council Victoria
http://www.cancervic.org.au/about-our-research/our-research-program/biomedical_research/apply_for_funding

Cancer Council NSW
http://www.cancercouncil.com.au/editorial.asp?pageid=890

Cancer Council Queensland
http://www.cancerqld.org.au/research/qcf_grants/qcf_researchGrants.asp

Cancer Council WA
http://www.cancerwa.asn.au/research/funding/

Cancer Council SA
http://www.cancersa.org.au/aspx/apply_for_funding.aspx

Cancer Council TAS
"http://www.cancertas.org.au/pages/research.php

Cancer Council ACT
http://www.actcancer.org/research/grant-applications.aspx

Cancer Australia
http://www.canceraustralia.gov.au/research-and-clinical-trials/overview.aspx

Queensland Clinical Trials Network
http://www.industry.qld.gov.au/dsdweb/v4/apps/web/content.cfm?id=6557

NHMRC Ethics Information
http://www.nhmrc.gov.au/health_ethics/index.htm
Information and guidelines on ethics and related issues in the fields of health and human and animal research.

National Cancer Research Network
http://www.ncrn.org.uk/Links/alphabetic.asp
UK-based listing of useful links

FACIT (Functional Assessment of Chronic Illness Therapy)
http://www.facit.org/
Organisation that manages the distribution of information regarding administration, scoring and interpretation of a range of questionnaires that measure health-related quality of life for people with chronic illnesses.

ProQolid (Patient-reported Outcome and Quality of Life Instruments Database)
http://www.qolid.org/
Database of literature and research tools associated with measuring quality of life.

Many thanks to the individuals and organisations who contributed to the development of this pathway, including:

  • the individuals who participated in case study interviews
  • COSA Clinical Research Professionals Group (in particular Cate O’Kane)
  • Haryana Dhillon
  • Paul Katris.