Role & Responsibilities Of A

Clinical Research Coordinator

Clinical Research Coordinator (CRC) is a specialized research person working with
and under the direction of the Principal Investigator .While the Principal
Investigator(PI) is primarily responsible for the overall designing, conducting, and
management of the clinical trial, the CRC supports, and coordinates the
regular clinical trial activities and plays a crucial role in the conduct of the study. By
doing these duties, the CRC works with the PI, sponsor ,department, and institution to
support and provide guidance on every related aspects of the study.
Every clinical research project may have one or more study coordinators depending
on the workload at the trial site. Clinical trials at site level can be roughly divided into
3 stages.
The three stages and the role of the coordinators at these stages are:
1) Before starting the clinical trial
2) During the conduct of the clinical trial
3) After finishing the clinical trial

1) Before starting the clinical trial:

the coordinator collects and completes the questions received form different Clinical

Research Organizations and Sponsors.

They have to collect required information from the PI, and send it back to the

respective people who contacted the site regarding the study.

In many processes a clinical study coordinator plays a vital role:
The

CROs after selecting clinical trial sites does Investigator meetings,

which areattended by the study coordinator along with the principal or coinvestigator. Before start of the trial CRCs are busy with submitting all study
documents to the ethics committee.
Documents to be submitted to the ethics committee includes the study protocol,

investigator brochure and informed consent forms with translation certificates.

After obtaining consent from the ethics committee the clinical trial can be initiated at
the site level.
2) During conducting of clinical trial:
During the screening time, the coordinator has to obtain informed consent from the

subject . The coordinators have to collect subjects previous medical history and
according to study protocol he/she has to conduct their scheduled visits.
After completion of all visit procedures the coordinators enter data in the case report

forms (CRF). CRFs are two types, one is paper CRF and another one is eCRF.
Duringa monitoring visit the CRAs also verify EC notifications and Investigator Site
Files (ISF). To keep updated documents is the duty of the CRC. Study coordinator
also has to maintain EC soaps, site SOPs and EC members list.
When the subjects come for next schedule visit, study drug accountability has to be

calculated by CRC. Along with that patient diaries have to be reviewed if applicable.
IVRS (Interactive voice response system) and IWRS to record the subject visit have
to be performed as per the study requirement. IVRS reports have to be maintained in
the ISFs. Investigational product is the major part in clinical trial and study
coordinators have to store the same in a proper condition and maintain required
temperature logs.
In report of any adverse events or serious adverse events that occurred at the trial

site, coordinators have to collect all necessary information such as start date, stop
date, severity, concomitant medications taken by the subject and the way

of administration. Also information related to any challenges, therapy provided to the

subject during the SAE, the recovery details and whether it is related to study drug or
not have to be collected.
Throughout the clinical trial the study coordinators have to check all Central lab reports and take
PI signatures on them to document that the PI reviewed the lab reports.
They are also responsible for giving telephonic reminders to the subjects regarding

the visits. If the CRC does the data entry then it is the study coordinators
responsibility tosolve all queries within 48 hours or as per time line given by the
sponsor. Queries are of three types; system generated queries, data management
generated queries and CRA generated queries.
3) After Close out of clinical trial:
Before a clinical research trial is closed at the site, study coordinators have to validate all
documents and all the documents need to be updated. On the final day CRA will verify all
documents. After verification of all documents by the CRA,the CRC will assist in archiving the
documents at site. The site has to maintain all study related records for 15 to 20 years.
With the many ongoing progressive researches in Pune, the demand of a CRC is increasing.

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Clinical Research review by CRB Solutions is enough to make you consider and
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2)Top 10 Clinical Research Companies in Pune