The document outlines the role of a Clinical Research Coordinator (CRC) in managing clinical trials, detailing their responsibilities from start to finish. Key duties include supporting the Principal Investigator, coordinating trial procedures, maintaining documentation, and ensuring patient safety. Additionally, the CRC is responsible for document verification and archiving following the trial's close.

1. Clinical
Research Coordinator(CRC)

2. CONTENTS
Introduction
Before the start of the clinical trial
During the conduct of the trial
After close out of the trial
1
2
3
4

3. INTRODUCTION
Clinical Research Coordinator
(also known as Study Coordinator)
works under
Principal Investigator
gets
involved
Start of
project
End of
project
Supports
management Coordinates in daily
trial activities
Number of CRC in trial depends
on workload at trial site

4. Accordance with
prescribed SOP
guidelines and
applicable
regulatory
regulations
CRC RESEARCH
Plays an integral
role in
mainly
responsible for
Principal
Investigator
Ensures that
& Ethical
manner
Responsible
for
Developing, implementing
and coordinating trial
procedures for successful
management of trial

5. BEFORE THE
START OF THE
CLINICAL TRIAL
Participating in
investigator meetings
Contracting with pharmaceutical
companies
Cost analysis and budget
negotiations
Preparation and
submission of EC dossier
to EC of site for approval
Complete Feasibility
Questionnaires

6. DURING THE
CONDUCT OF
THE TRIAL
Understanding of the study protocol and
must know well about the inclusion and
exclusion criteria
Preparing and maintaining
all the types of documents
Storage and study
drug accountability
Subject recruitment and
retention related activities
Participating with PI in AV and
informed consent process

7. DURING THE
CONDUCT OF
THE TRIAL
Maintaining IVRS and
IWRS
Record and report Adverse
event/Serious adverse event within
timelines and their follow up
Patient safety and care and
appropriate visit conduct for the
patient
Filling up-to date electronic case
report forms
Check all central lab reports
reviewed and signed by PI

8. AFTER CLOSE OUT OF THE CLINICAL TRIAL
 Before a clinical trial is closed at the site, study coordinators have to check all documents and all
documents have to be updated.
 After verification of all documents by the CRA, CRC will assist in archiving the documents at
site.
 The site has to maintain all study-related records for contracted length of time or 15 to 20 years
or longer.
 CRC plays a vital role in managing a clinical trial at the site level and acts as a link between the
Sponsor, Ethical Committee and Investigator.

9. REFERENCES:
• Role & responsibilities of a clinical research coordinator (slideshare.net)
• https://www.slideshare.net/JagritiBansal1/roles-and-responsibility-of-a-crc
• https://www.google.com/search?q=documents+images

10. THANK YOU
K.Bhargavi-005/0122
katkambhargavi75@gmail.com