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Valencia: "Our purpose is to ensure trial subject benefits from treatment"

You have heard of clinical trials but do you know who are the people involved in and/or behind clinical trials? What is a clinical research coordinator (CRC) and what is their role in clinical trials? Read on to find out, in this interview with Valencia, a Principal Clinical Research Coordinator at National Cancer Centre Singapore.

Q: What is the role of a clinical research coordinator (CRC)?

Valencia: A CRC plays a vital role in managing a clinical trial at the site. We provide support, facilitate and coordinate the daily clinical research activities while simultaneously, ensuring compliance to the study protocol, ICH Good Clinical Practice (GCP) and the applicable ethics and regulatory requirements under the Health Product Act. A CRC is also the liaison between the study sponsor, trial subject (patient) and site investigator.

Other responsibilities include assisting the investigator in screening and enrolment of subjects; scheduling assessments according to the study protocol; plan trial logistics; liaising with other clinical departments on study related procedures which sometimes lead to forming of new inter-department workflow for the study; handle administrative tasks required during the study conduct; assist in ethics and regulatory submissions as necessary; monitor subject’s compliance to study procedures and treatment; performing timely data collection and entry into the research case report forms; assisting the investigator in safety reporting according to specified reporting guidelines; maintaining and organising of the investigator site binders; track trial expenditures; and assisting in study closure and archival of the study files once the trial ends.

Q: Why do you want to work in clinical research?

V: I started out working as a registered nurse after I graduated. It was only when I studied overseas for my nursing degree that I developed an interest in clinical research. It was also around that time, when clinical trials and research were slowly evolving. When I returned from my studies and came across this career opportunity as a CRC in NCCS, I took it. 

Q: What is the most challenging part of your job?

V: There are many challenges in this job and not just one. But if I had to choose, then I think effective time management and being able to multi-task is perhaps the most challenging part of the job. Being in charge of a few studies at the same time and meeting study timelines, and data queries and database locks for the studies, on top of having to coordinate and handle the subjects in the clinics when they return for their study visits can be stressful.

Other than that, I think ensuring that trial subjects adhere to the study protocol schedules and procedures, and compliance to the study treatment is also another challenge. Sometimes, patients would request to change doctors' appointments or re-schedule the study procedures at the very last minute. This can be very disruptive especially since we cannot deviate too much from the study protocol’s allowable window period otherwise this would be reportable as a protocol deviation.

Lastly, learning how to communicate with the patients and handle the emotional aspects of the job can be a challenge. Some patients can stay on the trial for many years and over time they would have developed a bond with the CRC who looks after them while they are on the trial. It would be quite devastating to hear whenever a trial patient passes away after succumbing from their disease. We must learn to cope with the initial grief but also continue to get things done and move on.

Q: What is a common misconception of a CRC?

V: That we are simply just coordinators helping the doctors to schedule appointments and arrange tests for patients. What we do is actually much more than that. There is a purpose to ensure the subject benefits from the treatment.

Q: Any advice for someone who wants to work as a CRC?

V: He/she must be able to work independently, detailed-oriented, able to multi-task and work under pressure. A critical thinker to be able to solve day-to-day issues or problems at work is also essential.