Clinical Trial Coordinator
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Job Summary
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). |
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Required Skills:
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)
