The FSP Clinical Trial Coordinator I role at PPD is a remote, full-time position based in India, focused on providing administrative and technical support to project teams within clinical research. Here’s a summary of the key details and requirements:
Key Responsibilities:
- Administrative Support: Assist in site activation activities, document processing, and maintaining up-to-date systems like eTMF.
- Audit Readiness: Ensure files are reviewed according to SOPs, supporting audit readiness and regulatory compliance.
- Communication and Coordination: Facilitate communication between teams, coordinate the distribution of materials, and assist in regulatory submissions.
- Data Management: Analyze study metrics, reconcile findings, and assist with clarification of site documentation.
- Training and Support: Provide training to new staff and support the maintenance of study-specific documentation and systems.
- Feasibility and Site Selection: Contribute to the development of site lists and support local tiering of sites.
- Client Interaction: Liaise with global investigator services, maintain accounts and contact information, and ensure timely delivery of documents.
Requirements:
- Education: Bachelor’s degree in Life Science is preferred.
- Experience: 1-3 years in a Clinical Research Coordinator (CRC) or Clinical Trial Coordinator (CTC) role.
- Skills:
- Strong business communication skills.
- Knowledge of eTMF and ICH GCP guidelines.
- Proficiency in MS Office and clinical trial database systems.
- Ability to work independently or as part of a team.
- Good organizational and analytical skills, with attention to detail.
- Effective oral and written communication in English.
- Preferred Location: Candidates from Mumbai or nearby locations.
- Immediate Availability: The position requires someone who can join immediately.
