| Detail | For this role |
|---|---|
| Department | Clinical and Medical |
| Level | Entry level |
| Reports to | Principal Investigator |
| Direct reports | None |
| Experience | Fresher to 3 years in clinical trials or research coordination |
Clinical Research Coordinator job description template
Copy this job description, replace the text in square brackets and post it on your careers page or a job portal.
Job title: Clinical Research Coordinator
Department: Clinical and Medical
Reports to: Principal Investigator
Location: [City], [office, branch or site]
About the role
A Clinical Research Coordinator runs a clinical trial at the site level for a hospital or pharma sponsor. The person recruits and consents participants, schedules visits, collects data, maintains trial documents, and keeps the study compliant with the protocol, GCP and ethics committee rules. In India this role is the link between the investigator, sponsor and patient. A good coordinator keeps enrolment on track, data clean and query-free, and documentation audit-ready, so the trial runs on time and stands up to inspection.
Key responsibilities
- Screen, recruit and obtain informed consent from eligible trial participants as per protocol.
- Schedule and coordinate participant visits, tests and procedures on the study timeline.
- Collect and record trial data accurately in case report forms and the study system.
- Maintain the investigator site file and all essential trial documents in order.
- Ensure the study follows the protocol, GCP and ethics committee approvals at all times.
- Manage investigational product accountability, storage and dispensing records at the site.
- Resolve data queries from the sponsor and monitor within the agreed time.
- Report adverse events and protocol deviations promptly through the right channels.
- Prepare for and support sponsor monitoring visits and regulatory audits.
- Coordinate between the investigator, sponsor, lab and participants throughout the study.
Requirements
- Life science, nursing, pharmacy or BDS or MBBS degree
- Good Clinical Practice (GCP) certification
- Diploma in clinical research an advantage
- Fresher to 3 years in clinical trials or research coordination
KRAs and KPIs for a Clinical Research Coordinator
Key result areas for the appraisal form, each with a KPI you can measure every month or quarter.
| Key result area | How to measure it |
|---|---|
| Enrolment | Participant enrolment meets the site target within the recruitment window |
| Data quality | Case report form entries accurate with data queries resolved within the agreed time |
| Protocol compliance | Zero major protocol deviations attributable to coordination in the study |
| Documentation | Investigator site file audit-ready at every monitoring visit |
| Safety reporting | Adverse events and deviations reported within the required timeline every time |
| Retention | Participant retention held above the study target through the trial |
Skills and tools
Tools used day to day: Electronic data capture systems, Case report forms, Investigator site file, MS Excel, Trial management software.
Reporting line and career path
Next roles: Senior Clinical Research Coordinator, Clinical Research Associate, Clinical Trial Manager
Interview questions for a Clinical Research Coordinator
- Walk me through taking informed consent from a trial participant.
- How do you keep case report form data accurate and query-free?
- What do you do when you spot a protocol deviation?
- How do you keep the investigator site file audit-ready?
- How do you report an adverse event, and within what timeline?
- How do you keep participants engaged so they complete the study?
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What does a clinical research coordinator do?
A clinical research coordinator runs a clinical trial at the site level. They recruit and consent participants, schedule visits, collect and record data, maintain trial documents and keep the study compliant with the protocol, GCP and ethics rules. They resolve data queries, report adverse events and prepare for audits, acting as the link between investigator, sponsor and patient.
What qualifications does a clinical research coordinator need?
A life science, nursing, pharmacy, BDS or MBBS background is common, along with Good Clinical Practice certification. A diploma in clinical research helps for entry and growth. The role suits detail-oriented people who can manage documentation, follow strict protocols and coordinate many moving parts, so accuracy and integrity matter as much as the degree.
Is clinical research coordinator a clinical or non-clinical role?
It is a research role rather than a treating role. A clinical research coordinator does not diagnose or prescribe; they run the trial process: consent, visits, data, documentation and compliance. The investigator remains responsible for clinical decisions. The coordinator makes sure the study is conducted correctly, ethically and in a way that stands up to inspection.