Career Spotlight: Clinical Research Coordinator

Pharma IQ

Working as a clinical research coordinator or a clinical research associate can prove both a challenging and rewarding career. Those who excel in the profession often have strong scientific knowledge, excellent organisational skills and the ability to analyse and think logically.

These researchers are involved in the creation and implementation of clinical trials to establish if products are suitable for the market, and sometimes in the continued monitoring of drugs once they are released.

In these roles they are expected to interact with members of the medical community, the pharmaceutical industry and, at times, the public because of their position at the forefront of pharmaceutical research. 

The fast rate of change within the pharmaceutical industry and the increasingly short periods of time in which companies are looking to get products to market, means it is essential for those working in clinical research to remain on top of all the latest developments.

The role of a clinical research coordinator or associate

The tasks they are expected to undertake are far ranging. These research roles vary slightly. An associate monitors a clinical trial and must be independent of those carrying out the investigation, while a coordinator works directly under a principle investigator at a research site, as defined by the Association of Clinical Research Professionals (ACRP).

Day-to-day tasks can include developing and writing trial protocols and delivering these to a committee, designing data collection forms, verifying data, compiling and filing reports and preparing final conclusions.

In addition to the more lab and office-based tasks, clinical research coordinators and clinical research associates can find themselves coordinating with ethics committees, liaising with doctors involved in the trial and training staff at research sites to correct industry standards.

Job responsibilities change depending on the research organisation they are working for, but are likely to include a number of the above tasks.  These jobs also often offer opportunities for flexible and part-time working.

Clinical research training and certification

Training for clinical research jobs will vary depending on the tasks the role encompasses. Those working within the roles often come from varied employment and education backgrounds, meaning they will have different clinical research training needs.

A background in biology, chemistry, pharmacy, toxicology or nursing could serve those looking to work in clinical research well, and those with lower qualifications are more likely to begin at the clinical research coordinator level.

General training for the role is likely to include clinical research and data management, good clinical practice, ethical and quality issues and operating procedures. Often this instruction will be given in-house, but training and certification is available from a number of external industry bodies.

A number of certification schemes for those working in these jobs are available through ACRP, which represents workers in more than 30 countries.

ACRP tests, which were first created in 1992, are globally harmonised and according to surveys by the organisation, offer increased company marketability, enhanced recognition and reinforced professional standing.

The Society of Clinical Research Associates provides its own clinical research certification scheme, which covers ethics, regulations, safety reporting and assesses critical thinking skills.

Training is also provided by institutions including the Institute of Clinical Research, the Drug Information Association and the Society for Clinical Data Management among others.