clinical research

1. CRPV 1
15-12-2021
Presented by,
ASHWIN RAM R
Master of pharmacy
Pharmacology Department
KMCH COLLEGE OF PHARMACY
ROLES & RESPONSIBILITIES OF
CLINICAL RESEARCH
COORDINATOR
CLINICAL RESEARCH AND
PHARMACOVIGILANCE

2. CRPV 2
 Clinical Research Coordinator (CRC) is a specialized research person
working with and under the direction of the Principal Investigator.
 While the Principal Investigator(PI) is primarily responsible for the
overall designing, conducting, and management of the clinical trial, the
CRC supports, and coordinates the regular clinical trial activities and
plays a crucial role in the conduct of the study.
 By doing these duties, the CRC works with the PI, sponsor ,department,
and institution to support and provide guidance on every related aspects
of the study.
WHO IS CRC
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3. CRPV 3
Clinical research coordinators have many responsibilities that need to be
carried out to the best of their ability.
1. Maintaining records of all studies as per the guidelines.
2. Sticking to all ethical standards.
3. Sticking to all the regulatory standards set.
4. Administering questionnaires.
5. Managing the budget dedicated to the research.
RESPONSIBILITIES
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4. CRPV 4
6. Overseeing the running of the trials as smoothly as possible.
7. Understanding and engaging with the subjects so as to know all
issues.
8. Making sure that all equipment and supplies that are necessary for
the success of the study are working and in stock.
9. Participating in the recruitment efforts of the participants.
10.Working with the laboratories so as to share findings.
RESPONSIBILITIES
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5. CRPV 5
The qualifications of a clinical research coordinator usually depend on your
locations or employer. In most cases, for you to become a clinical research
coordinator you should:
Have an associate nursing degree or any related field.
Experience of two years within the healthcare industry.
Analytical mindset.
Be attentive to detail.
Have interpersonal skills which are exceptional.
Be ready to continue learning even without being prompted to do so.
Great skills in organizing.
Have great verbal and written communication skills.
REQUIRMENTS
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6. CRPV 6
Every clinical research project may have one or more study
coordinators depending on the workload at the trial site.
Clinical trials at site level can be roughly divided into 3 stages.
The three stages and the role of the coordinators at these stages are:
ROLE OF CRC
BEFORE
STARTING
THE TRIAL
DURING
CONDUCTING
THE TRIAL
AFTER CLOSE
OUT OF
CLINICAL
TRIAL
1 3
2
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7. CRPV 7
The coordinator collects and completes the questions received form
different Clinical Research Organizations and Sponsors.
They have to collect required information from the PI, and send it back
to the respective people who contacted the site regarding the study.
In many processes a clinical study coordinator plays a vital role:
• The CROs after selecting clinical trial sites does Investigator
meetings, which are attended by the study coordinator along with
the principal or co-investigator.
BEFORE STARTING THE
TRIAL
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8. CRPV 8
• Before start of the trial CRC’s are busy with submitting all study
documents to the ethics committee.
• Documents to be submitted to the ethics committee includes the study
protocol, investigator brochure and informed consent forms with
translation certificates.
• After obtaining consent from the ethics committee the clinical trial can
be initiated at the site level.
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9. CRPV 9
 During the screening time, the coordinator has to obtain informed
consent from the subject.
 The coordinators have to collect subjects previous medical history and
according to study protocol he/she has to conduct their scheduled visits.
 After completion of all visit procedures the coordinators enter data in
the case report forms (CRF).
 CRF’s are two types, one is paper CRF and another one is eCRF.
 During a monitoring visit the CRA’s also verify EC notifications and
Investigator Site Files (ISF).
DOING CONDUCTING THE
TRIAL
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10. CRPV 10
 To keep updated documents is the duty of the CRC. Study coordinator
also has to maintain EC SOP’s(standard operative procedure), site SOP’s
and EC members list.
 When the subjects come for next schedule visit, study drug
accountability has to be calculated by CRC.
 Along with that patient diaries have to be reviewed if applicable.
 IVRS (Interactive voice response system) and IWRS to record the
subject visit have to be performed as per the study requirement.
 IVRS reports have to be maintained in the ISF’s.
 Investigational product is the major part in clinical trial and study
coordinators have to store the same in a proper condition and maintain
required temperature logs.
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11. CRPV 11
 In report of any adverse events or serious adverse events that occurred
at the trial site, coordinators have to collect all necessary information
such as start date, stop date, severity, concomitant medications taken by
the subject and the way of administration.
 Also information related to any challenges, therapy provided to the
subject during the SAE, the recovery details and whether it is related
to study drug or not have to be collected.
 Throughout the clinical trial the study coordinators have to check all
Central lab reports and take PI signatures on them to document that
the PI reviewed the lab reports.
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12. CRPV 12
 They are also responsible for giving telephonic reminders to the
subjects regarding the visits.
 If the CRC does the data entry then it is the study coordinators
responsibility to solve all queries within 48 hours or as per time line
given by the sponsor.
 Queries are of three types; system generated queries, data management
generated queries and CRA generated queries.
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13. CRPV 13
 Before a clinical research trial is closed at the site, study coordinators
have to validate all documents and all the documents need to be
updated.
 On the final day CRA will verify all documents. After verification of all
documents by the CRA, the CRC will assist in archiving the documents
at site.
 The site has to maintain all study related records for 15 to 20 years.
AFTER CLOSE OUT OF
CLINICAL TRIAL
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14. CRPV 14
https://ccrps.org/clinical-research-blog/tag/clinical+research+coordi
nator
https://research.wustl.edu/about/roles-responsibilities/clinical-resear
ch-coordinator/#Effort
https://acriindia.com/blog/roles-and-responsibilities-of-a-crc/
https://www.glassdoor.co.in/Job-Descriptions/Clinical-Research-Coor
dinator.htm
REFERENCE
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