An Insight on Clinical Research Coordinator (CRC) Job Description

by | Sep 7, 2016

If you are looking to start your career in clinical research as clinical research coordinator (CRC) (also known as clinical trial coordinator/ clinical study coordinator) then you must be aware of the job description, duties and responsibilities of a CRC before stepping into this profile.

While most clinical research aspirants are aware of potential and basics of clinical research, few of them are really well known about the job description, duties and responsibilities of a clinical research coordinator (CRC).

If you are one of them, don’t worry. This blog post will help you to resolve few of your queries:

  • What is a Clinical Research Coordinator (CRC)?
  • What does Clinical Research Coordinator (CRC) do?
  • What is the role of a Clinical Research Coordinator (CRC) in a study?
  • What are different duties performed by a clinical trial coordinator during a clinical trial phase?

What is a Clinical Research Coordinator (CRC)?

A Clinical Research Coordinator (CRC) is a healthcare professional who works under the guidance of a Study Investigator/ Principal Investigator (PI) to coordinator day-to-day clinical trial activities in compliance with Good Clinical Practices (GCP) guidelines, Clinical Study Protocol and regulatory guidelines.

Role of Clinical Research Coordinator (CRC)

A CRC works as an integral part of a clinical trial phase. They also act a principal communication link between a study site and sponsor. Typically, a CRC is a multitasker whose primary role is:

  • To act as an administrator and organizer of the team,
  • day to day communication with team and other stakeholders
  • management of clinical trial data generated
  • follow and implementing compliance at site
  • Managing and maintaining inventory at site
  • Patient Management under the guidance of PI
  • Completing Paperwork and documents submissions.

Job Description of a Clinical Research Coordinator (CRC)

A site investigator may distribute all or partial activities to a CRC. During a clinical trial phase, a CRC is responsible for various duties before initiation of a clinical trial, during the conduct of a clinical trial and after completing/ termination of a clinical trial phase.

Responsibilities of a Clinical Research Coordinator (CRC) – Before Initiation of Clinical Trial Phase

  • Financial Budgeting and Negotiation
  • Attending Investigator’s Training Meeting
  • Submission of Documents to IRB
  • Investigator Site Personnel Training
  • Preparation for Site Initiation Visit (SIV)
  • Preparation & Documentation of Investigator Site File
  • Clinical Trial Registration
  • Procurement of Equipment and Instruments

Responsibilities of a Clinical Research Coordinator (CRC) – During Conduct of Clinical Trial Phase

  • Compliance With Study Documents and Procedures
  • Study Subject Screening, subject’s Recruitment, and Randomization
  • Recording Trial Data in Case Report Forms
  • Effective Communication with Sponsor, IRB, Subjects and Study Team Members
  • Accountability of IP
  • Serious Adverse Event Reporting
  • Record Maintenance and Documentation
  • Facilitating & Coordinating Clinical Trial Monitoring Visit
  • Facilitating Audit Visit
  • Ensuring Safety of Study Subjects
  • Coordination with Pharmacist and Central Lab
  • Regular Financial Tracking

Responsibilities of a Clinical Research Coordinator (CRC) – At Close-out/ Termination of Clinical Trial

  • Updates to All
  • Document Archival

To start your career in clinical research as a CRC, you must have detailed knowledge in clinical trial concepts, applicable ICH/ regulatory guidelines along with responsibilities of a CRC. It would always offer you an added advantage to get a job as CRC if you have gained any experience via an internship, certification or degree.

Our online certification course Certification Training for Clinical Research Coordinator (CTCRC) will serve you as a perfect starter course to excel your career as a Clinical Research Coordinator (CRC).

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