Clinical Project Specialist
Job Summary
To support the execution of clinical trials, the full-time remote Clinical Project Specialist will manage study planning, site activation, and vendor management while collaborating with project leadership and cross-functional teams.
Key responsibilities
- Document and update study plans, ensuring communication with the team and sponsors
- Oversee study document development and manage site activation and close-out activities
- Participate in TMF quality control and audits, ensuring compliance with regulations and guidelines
Required qualifications
- 2-4 years of progressive experience in clinical research
- Knowledge of FDA regulations and ICH-GCP guidelines
- Advanced proficiency in MS Office software, including Word, Excel, and PowerPoint
- Proficiency in electronic Trial Master File (eTMF) management
- Ability to lead and coordinate activities and team members effectively
Complete Job Description
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