Role of CRC in Clinical Research

Clinical Trials are conducted at sites which are generally hospitals, where well qualified and experienced investigators (doctors) conduct the clinical trials. A Clinical Research Coordinator (CRC) is a specialized Clinical research professional who generally works at site, under the supervision/direction of theinvestigator. The Principal Investigator(PI)is generally responsible for the overall conduct,and management of the clinical trial at site,while the CRC is responsible for supporting the investigator as well as the study team and coordinatingwith the daily clinical trial activities. CRC plays a significant role in the conduct of the study. CRC works with the PI, the department staffs(at site where the trial is being conducted), sponsor, and institution to support and provide guidance on administration of the project.The CRC reports his/her updates related to the clinical study, compliance to the study protocol etc., while conducting the clinical operation, financial aspects, site staff activities and all other study related aspects to the investigator.

CRC will be involved in some administrative tasks too. CRC generally coordinate with the PI, the department and the administration at site to ensure that study related activities are performed in accordance with regulatoryrequirements, in compliance to IRB/IEC norms,in compliance with sponsor's policies and procedures. Sometimes CRC will assist the PI in the development of materials and tools necessary to properly train the study team at site and maintain documentation of the training records.

CRC cooperates with site compliance and ensures the study conduct according to sponsor's plan, helps to facilitate monitoring and auditing visits. He/she notifies appropriate institutional(site) officials about external audits by regulatory authorities (RA) and sponsors.CRC collaborates with PI to respond to any audit findings and implement suggested recommendations. He/she cooperates with site as well as to the sponsor agency about study compliance to protocol, SOP, GCP and monitoring results related to human subject protection and reports the incidences of noncompliance to the PI.

CRC also plays some major roles in preparation of scientific proposal related to the study, budget proposal preparation, protocol review, planning for the research conduct etc. Some other roles of CRC include preparation and organization of study files, such as regulatory binders, attending investigator meetings as required/requested by the PI.He/she maintains the study materials which include informed consent documents, case report forms (CRFs), enrolment logs, drug/device accountability logs, temperature maintenance log etc. During the clinical research operations the CRC assists principal investigator (PI) and the study team to understand the clinical operations related procedures thoroughly and if the team members need any revision he/she will provide appropriate training and help the team members. He/she documents date of training along with the signatures of study personnel trained on study specific training log maintained at site.

One of the major tasks of a CRC is to be involved in patient recruitment process.CRC directly conducts or involves in the informed consent process, counselling the patients, answering their questions related to the study. He/she is responsible for obtainingsignatures and dates on informed consent form (ICF) in appropriate places and also assures that amended consent forms (whenever applicable) are appropriately implemented and signed.

CRC helps in the screening of subjects for their eligibility according to protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibilityfor inclusion or exclusion and coordinates corresponding participant's tests and procedures. He/she ensures data is collected according to the requirement of the protocol, assures that Case Report Forms(CRF) are completed within time,study timelines are maintained. Another important duty of CRC is to maintain adequate inventory of study supplies such as investigational drugs/devices, suitable control substances etc.

CRC also completes study documentation and maintains study files in accordance to sponsor requirements, retains all study records in accordance with sponsor requirements. Overall CRC Works with the PI in day to day activities of the study.CRC promotes theethical conduct of research by reportingsuspicions of misconduct in research. At the closeout part he/she assists the PI in submission of accurate documents to ethics committee,site contract related duties according to sponsor specific criteria. Thus CRC plays the role of "Face of the Clinical Trial" at site.

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