According to Sami Anwar – CEO of Zain medical center, it is essential to aware people about the role and responsibilities of a clinical research director. Especially those who want to start there as a clinical research coordinator.
Before you talk about the role and responsibilities of a clinical research coordinator, let’s first find out who the clinical research coordinator is?
The clinical research coordinator is a professional who works with and under the supervision of the principal investigator. The role of a principal investigator is to design, conduct, manage the clinical trial, and coordinate the everyday activities.
Let’s explore the role of a clinical research coordinator in detail.
Before conducting the clinical trial
The role of a coordinator before starting the trial is to collect and completes the questions received from various different clinical research organizations. Further, they need to collect information from the principal investigator and send it back to the particular individual who contacted the site regarding the study. Documents required to submit to the ethics committee which includes investigating brochure, the study protocol, and informed consent forms with translation certificates.
Once the consent has been obtained from the ethics committee the clinical trial can be started at the site level.
During the conduct of the clinical trial
During the time of screening, the responsibility of a coordinator is to obtain a previous medical history and as per study protocol, he has to conduct their scheduled visits. Once the visit procedure has been completed, it is the responsibility of the coordinator to enter the data in the case report form (CRF). Further, he has to maintain EC soaps, site SOP and EC member list.
In case any adverse event happens at the trial site, coordinates have to obtain all the necessary information, including the day it started, the day it ends, severity, associated medications taken by the respective individual and the way of administration. In addition, information associated with challenges, therapy offered to the individual during the SAE, the details of recovery have to be collected. No matter if it is related to the study drug or not.
Also, it is the responsibility of the coordinator to check all the central lab reports and ask the principal investigator for signature on the document that PI reviewed the lab reports.
After conducting the clinical trial
After the closure of a clinical research trial at the site, the responsibility of the coordinator is to validate all documents and need to update them. On the last day, it is the responsibility of the CRA to verify all documents. Once all the documents are verified by the CRA, the responsibility of CRC is to assist in achieving the documents at site.
Sami Anwar – CEO of Zain medical center says today the demand of a CRC is increasing for clinical research profession. If you want to add something in the role and responsibility of a clinical research coordinator, you can write your feedback below in the comment box.