Clinical Research Study Coordinators

Clinical Research Coordinator:  The backbone of the clinical trial site

While the principal investigator is responsible for the overall conduct and management of the clinical trial, the clinical research coordinator or the CRC is the facilitator who supports the clinical trial activities on a day to day basis at the clinical trial site. The CRC plays an important role by working along with the principal investigator and the CRO or Sponsor to facilitate the coordination of the clinical trial. The CRC reports mainly to the principal investigator.  Some of the main administrative roles performed include:

  • Coordinating with the Principal investigator to ensure that the clinical trial is being performed in accordance with the federal regulations and sponsoring agency policies and procedures.
  • Assistance to the principal investigator to develop materials and training tools which are needed to train the rest of the staff involved in the clinical trial.
  • Assists the PI and institution to respond to any audit findings and implement approved recommendations.
  • Assists the PI where needed in development of accountability logs as well as case report forms and enrolment logs.
  • During the conduct of research, the study coordinator studies the protocol well to understand the timelines, inclusion as well as exclusion criteria and maintains confidentiality and privacy protections of subjects.
  • Helps in the collection of documents needed in initiating the study and submitting to sponsor like the FDA forms 1572 and CVs.
  • Works with the PI in implementing recruitment strategies to gain approvals.
  • Takes part in the informed consenting process to answer related questions and obtain signatures and dates on the appropriate places.
  • Registering of subjects in screening on IVRS and checking the eligibility of subjects along with the PI.
  • Data collection as per the protocol and assuring timely completion of case report forms while maintaining study lines.
  • Inventory maintenance as well as handling of investigational drugs and devices helping with investigational drug/device accountability. 
  • The study documentation is done according to GCP and documentation and maintenance of study files is done according to sponsor requirements.
  • Effective communicator between the PI and the sponsor or CRO
  • Works with the PI to help with the day to day activities of clinical studies, helping with problem solving, and management of protocol as well as communication.
  • Promotes ethical clinical trial conduct and helps to report adverse events and serious adverse events on time to the sponsor.
  • Helps with smooth study closeout and maintenance of files in a secure way for any future reference. 

Thus, clinical research coordinators are at the heart of a clinical trial and works together with the PI to successfully conduct a clinical trial. A good research coordinator is investigative and very inquisitive making them curious people. They do also display good leadership and team work qualities to help with running an entire team together. Clinical research coordinators have the ability to persuade and influence others and the success of a clinical research coordinator lies in how much inter personal relationships one holds, integrity and the knowledge of the protocol being conducted. They should also have the ability to cope to pressure and work on tight deadlines.

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