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:
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:
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 are attended by the study coordinator along with the principal or co-investigator. Before start of the trial CRC’s 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). CRF’s are two types, one is paper CRF and another one is eCRF. During a monitoring visit the CRA’s 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 SOP’s 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 ISF’s. 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 to solve 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.
In the race of many organizations CRB Tech Solutions has it own name in offering Clinical Research Training.