FSP Clinical Trial Coordinator - Site Record Coordination
- Hyderabad, India · Remote
- Full-time
- Posted
Skills
Job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Clinical Trial Coordinator (Site Record Coordination)
Role Summary
The Clinical Trial Coordinator I supports clinical trial operations by managing site documentation, TMF/eTMF activities, clinical systems, site communications, and study records to ensure timely, compliant, and high-quality trial execution. The role collaborates with study teams, investigators, and cross-functional stakeholders to support study start-up, conduct, and closeout activities.
Key Responsibilities
•Plan, distribute, collect, and track site records through Site Collaboration tools and ensure timely TMF completion.
•Perform quality reviews of study documentation and maintain TMF/eTMF, ISF, and study records.
•Support clinical systems including CTMS, Activate, and eTMF, ensuring databases and trackers remain current.
•Coordinate with sites and internal teams for document collection, site start-up, feasibility, and regulatory activities.
•Review study metrics, resolve documentation findings, and communicate site-related risks and updates.
•Support vendor management, regulatory submissions, and site communication activities.
•Maintain compliance with ICH-GCP, SOPs, Good Documentation Practices, and applicable regulations.
Required Skills
•Clinical Trial Operations
•TMF/eTMF & ISF Management
•CTMS and Clinical Trial Systems
•Site Collaboration & Site Documentation
•ICH-GCP and Good Documentation Practice
•Regulatory Documentation
•Communication & Stakeholder Management
•Microsoft Office Suite (Excel, Word, PowerPoint)
Education & Experience
•Bachelor's degree preferred in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related discipline.
•1- 3 years of experience in Clinical Research, Clinical Operations, TMF/eTMF, Clinical Trial Coordination, or Trial Support functions
•Hands on work experience in global clinical trials.
•Hands on working experience in eTMF system preferably Veeva.
•Hands on working experience in managing site related files and site collaborations ( preferably for Europe and US sites)