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.
- 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.
• Clinical Trial Operations
- 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)
- 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)