Clinical Project Specialist
Job Summary
To support the execution of clinical trials, the contract Clinical Project Specialist will manage study planning, site activation, and vendor management while working remotely in a collaborative environment.
Key responsibilities
- Document and update study plans, ensuring alignment with team and sponsor requirements
- Oversee site activation and close-out activities, mentoring team members throughout the process
- Participate in TMF QC activities and audits, ensuring compliance with regulatory standards and quality control of deliverables
Required qualifications
- 2-4 years of progressive experience as a clinical research professional
- Knowledge of FDA regulations and ICH-GCP Guidelines
- Advanced proficiency in MS Office software, including Word, Excel, and PowerPoint
- Proficiency in eTMF
- Ability to lead and coordinate activities and team members effectively
Complete Job Description
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