Clinical Trial Coordinator - Job Description

Particulars

Details

Job Title

Clinical Trial Coordinator

Department

Clinical Research / Academic & Research Department

Reporting To

Principal Investigator / Head of Research / Medical Director

Location

Hospital / Research Centre

Employment Type

Full time

Qualification

Masters in Clinical Trial Management/Clinical research

Job Purpose

Coordinate and manage pharma-company-based clinical trials while supporting DNB, Fellowship and postgraduate thesis activities, research data collection, publications and regulatory compliance.

Key Responsibilities

Area

Responsibilities

Clinical Trial Coordination

Pharma-company-based sStudy start-up, coordinate feasibility studies, protocol implementation, recruitment, scheduling and sponsor liaison. Maintenance of documents, files related to the studies. Follow up of patient and their timely schedules related to the drug trial. Approaching pharma companies and spotlighting the institution’s capabilities and capacity for conducting clinical trials.

Regulatory & Ethics

IEC submissions, amendments, annual reports, study closure and compliance documentation.

Data Management

CRF/eCRF completion, source on and offline documentation, query resolution and quality checks.

Safety Reporting

Coordinate AE, SAE and SUSAR reporting, filing and notifying the concerned authorities in-house and external governmental agencies.

Monitoring & Audits

Support monitoring visits,



audits, inspections and CAPA closure.

Thesis Coordination

Coordinate DNB, Fellowship and PG theses, protocols, approvals, conducting examinations (written & clinical) and progress tracking.

Research Material Collection

Collect clinical records, imaging, laboratory data and maintain research repositories.

Publication Support

Assist in literature review, manuscript preparation and journal submission.

Computer Knowledge

Adequate knowledge and experience of handing computers, laptops and MS Office (Word, PowerPoint, Excel).

Job Requirements: Clinical trial coordination, Feasibility studies, Protocol implementation, Recruitment, Scheduling, Sponsor liaison, Document maintenance, Patient follow-up, Regulatory submissions, IEC submissions, Amendments, Annual reports, Study closure, Compliance documentation, Data management, CRF/eCRF completion, Source documentation, Query resolution, Quality checks, Safety reporting, AE reporting, SAE reporting, SUSAR reporting, Filing, Notification to authorities, Monitoring visits, Audits, Inspections, CAPA closure, Thesis coordination, Thesis protocols, Approval processes, Conducting examinations, Progress tracking, Research material collection, Clinical records collection, Imaging data, Laboratory data, Research repositories, Publication support, Literature review, Manuscript preparation, Journal submission, MS Office (Word, PowerPoint, Excel)

📌 Clinical Trial Coordinator (Kochi)
🏢 HIRESTAR JOB BANK
📍 Kochi