Guide to the Clinical Research/Study Co-ordinator (CRC or SC) Role

A clinical research cordinator (CRC) is responsible for sets up and conduct of a clinical trial at a
trial site. These may be trials conducted by pharmaceutical companies, contract research
organisations (CROs), or local researchers. CRCs can also be known as Study Nurses, Trial
Nurses, or Study Coordinators.
Typical work activities
As for the CRA role, the job description for CRCs varies depending on the type of trials being run,
the experience of the trial site staff or co-ordinatory, the size of the research group, and the trial
site location (private or public institution). Usually, the smaller the group or the less commerciallyfunded the research, the greater the responsibility of the co-ordinator.
The CRC role may involve some or all of the following duties:

Preparation of the site for selected trials including:o Liasing with trial investigator to ensure adequate time, staff and resources are
allocated;
o Assessing logistics and feasibility of the study from a procedural and safety aspect;
o Preparing study documentation (for example patient information and consent forms,
advertising, patient aids, protocol, safety documentation, submission forms) for
application and approval by the appropriate human research ethics committee;
o Completing the regulatory application (as appropriate);
o Negotiating the clinical trial budget with research group or study sponsor;
o Negotiating the use of facilities in other departments for the clinical trial;
o Taking part in team meetings and study training days; (Note: some travel may be
required for commercially sponsored trial investigator meetings).
o Assisting with the review of draft CRF's and protocols (if not a commercially funded
trial);
o Developing volunteer recruitment plans
o Ensuring that the clinic is prepared (time and space) for trial volunteer recruitment
procedures and visits;
o Ensuring that all equipment required for the study is in place, and regularly
maintained.
Tracking the progress of the study and reporting to study sponsor or research group;
Identification and screening of potential volunteers for trial suitability;
Responsibility, in conjunction with trial investigators (doctors), for maintaining volunteer
welfare, comfort and safety.
Assess, record, report and initially manage adverse events of volunteers, reporting to the
trial investigator in a timely manner. Maintain adverse event logs for selected studies.
Facilitate expedited safety reporting to and from sponsor and ethics committees;
Perform drug accountability (This may be in conjunction with a hospital pharmacy,
depending on local procedures).
Ensure good quality data collection in accordance with ICH GCP which involves:o Accurate and legible recording in the medical notes and Case Record Forms (CRF)
o Prompt resolution of data queries raised on CRFs.
Be responsible for trial sample collection and/or processing and/or shipping for lab analysis,
as per trial protocol and SOP guidelines in the absence of clinical research technicians.
Spend considerable time filing and collating trial documentation and reports;

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Archive documentation at the end of trials.

preparing final reports and occasionally manuscripts for publication (if not a commerciallyfunded trial).
Attend training (therapeutic, regulatory, skills) as appropriate, and keep personal training
files.
Ability to train new trial staff in study procedures.
Develop and/or update trial site standard operating procedures (SOPs).

Skills required
The CRC role is a very paperwork intensive and collaborative role. Therefore the CRC needs to
have:

Nursing skills are usually preferred, but trial sites may be able to accommodate other
backgrounds, depending on the CRCs responsibilities at that site.
Good communication and co operation skills
Good attention to detail, for the collection and recording of data
Good administrative skills, and preferably good computer literacy.
Appreciation for and commitment to meeting deadlines and delivering on trial targets.
Ability to multi-task
Ability to adapt to/cope with change within trials and/or the internal/external environment;
Ability to work independently and as part of a team;
High regard for patient safety and well-being
Ability to build rapport with many different stakeholders (eg patients, doctors, other
department staff and/or trial sponsor staff) in order to facilitate conduct of the trial and use
of local facilities.
Good negotiation skills, for dealing with sponsors, other departments and trial investigators.
Strong technical knowledge of not only the therapeutic area, but also of the importance of
trial protocols, site standard operating procedures, and the regulatory framework of trials.
For commercially funded trials, an appreciation of and flexibility to work with the challenges
of working on multinational projects including different time zones or cultural/language
backgrounds, and working with contractors vs sponsors directly.

PROs and CONs of the CRC Role

Depending on your perspective, the following may be considered pros or cons for being a CRC:

CRCs work both independently and in teams and are usually busy.
CRCs sometimes need to travel to attend investigator meetings, usually at the start of a
trial. The considerations for travel include:
o The timing cannot always be planned.
o Travel can be within country or overseas. Overseas travel is increasingly in
economy class because of tight budgets.
o Travel is often at short notice and outside normal working hours (including early or
late flights, or weekends).
o You may be alone when travelling.
o Travel may impact family or social commitments.
There is unlikely to be shift work, but deadlines, global teams and the availability of
volunteers for visits, may mean the day is not 9-5 all the time. It would be important to

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establish with the research group the expectations and flexibility around working
arrangements.
While the types of tasks might remain the same from day to day, each day is rarely the
same. There are always different challenges to overcome, different deadlines, different
volunteers, different trials and different teams to work with in-house and externally.
CRCs get to see and learn about the latest potential treatments before they widely
available.
CRCs typically have better relationships with their volunteers as they see them on a
regular basis. They often become someone the volunteers rely on for more than just their
trial care, particularly in older patient trials.
In larger research teams, there is the possibility to specialise in types of trials or trial tasks,
progress to project management type roles, or become clinical nurse educators. Some
CRCs also decide to move into industry and transition into CRAs.

Basic Interview Tips

If you dont have experience in clinical research, you might like to talk to other CRCs to get
an appreciation for how the CRC role differs from being a nurse, such that you can share
awareness of the differences in an interview.
You might like to become familiar with basic clinical research terminology and acronyms,
such as ICH-GCP, SDV, CRF, CRO or the different phases of clinical trials. An interviewer
wont expect you to know everything, but will be impressed by any initiative you have
shown to learn something.
Be able to say why you want to be a CRC;
Be prepared to answer questions about your ability to travel;
Have specific examples from your past that display the above skills, even if they are not
within a prior clinical research role.

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