Clinical Project Specialist
Job Summary
To support the execution of clinical trials, the contract Clinical Project Specialist will manage study coordination and oversight remotely, ensuring compliance, facilitating site activations, and mentoring team members throughout the project lifecycle.
Key responsibilities
- Document and review study plans, ensuring they are updated throughout the project
- Oversee site activation and close-out activities, mentoring staff involved in these processes
- Ensure compliance with FDA regulations and ICH-GCP guidelines while managing TMF quality control activities
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 electronic Trial Master File (eTMF) systems
- Ability to lead and coordinate activities and team members effectively
Complete Job Description
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