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 Positive Documentation Practice
- Regulatory Documentation
- Communication & Stakeholder Management
- Microsoft Office Suite (Excel Word PowerPoint)

Education & Experience

- Bachelors 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)

Required Experience:

IC

📌 FSP Clinical Trial Coordinator Site Record Coordination (Mumbai)
🏢 Thermo Fisher Scientific
📍 Mumbai