Tuesday, 14 October 2014

Clinical Research Coordinator - Roles and Responsibilities

Clinical Research Coordinator (CRC), research coordinator or site coordinator is a specialized professional who assures uninterrupted and ethical conduct of a clinical trial at institution/hospital. AlthoughPrincipal Investigator (PI) is largely responsible for proper conduct of a clinical study; CRC shares the onus by working in coordination with PI under his supervision. Like PI and co-investigators; the CRC is an integral member of the team who performs clinical trial in accordance with regulatory guidelines and institutional requirements. CRC acts as an intermediary between trial subjects, institution and sponsor on ethical, personal and financialaspects of trial. Largely, CRC remains involved in almost every step of the study.
Clinical Research Coordinators performs the following activities:
  1. CRC collects the updated and signed resume of each member of the investigator team. He/she ensures the timely completion of pretrial documents including form 1572, financial disclosure form, undertaking from the PI and confidentiality non-disclosure agreement.
  2. Helps PI in determining study feasibility questionnaire and maintaining liaison with the study sponsor.
  3. Assists PI in recruiting subjects as per the inclusion and exclusion criteria predefined in study protocol.
  4. Participates in informed consent process and ensures that all the trial related questions of participants are answered to their satisfaction. He/she obtains duly signedand dated informed consent forms from subjects. Furthermore, he/sheensures that amendments to consent forms are appropriately implemented and signed.
  5. Monitors day to day progress of trial and reports to concerned authorities.
  6. CRC ensures timely conduct of protocol specified investigation of subjects. CRC also makes sure that specimens are properly labeled, packed and stored before shipping them to labs. He/she keeps track of the reports obtained from laboratories.
  7. Collects generated data as per pre-specified protocol and assures timely completion of Case Report Forms.
  1. Performs inventory management and ensures adequate and continuous supply of investigational drugs/devices and other required materials.
  2. CRC maintains study documents, records and files in accordance with sponsor requirements including but not limited to, consent forms, source documentation, narrative notes etc. Moreover, he/she retains these records as per institution/sponsor requirements for specified time period.
  3. Assures effective and ongoing communication with sponsor, research participants and PI during the course of the study.
  4. CRC coordinates with investigator, sponsor and IRB/IEC to confirm the conduct of trial in agreement with regulatory requirements.
  5. Actively participates during the monitoring visits, audits & inspections by the sponsor’s representative.
  6. CRC confirms that study gets completed as per the specifiedtimelines
  7. Once the study is closed, CRC maintains the inventory of archived documents.

Thus CRC plays a pivotal role in various activities like conduct of the study, protection of human subjects and eventually successful completion of study. Considering steep rise in number of clinical trials and their overtly complex designs, an expert and well trained CRC has become an obligation for sponsors. Thus, proficient CRCs are integral to the safe and effective performance of clinical trials.

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