Research Site Specialist
The primary responsibility of a Research Site Specialist is to ensure the integrity and safety of clinical studies by ensuring compliance with regulatory guidelines.
Key Responsibilities
* Participate in site qualification, conduct initiation visits, train personnel, and prepare reports.
* Review on-site files, Case Report Forms, and source documents for completeness and compliance.
* Ensure timely transmission of clinical data to data management and review data queries.
* Conduct close-out visits, including final IP reconciliation and TMF documentation.
Required Skills and Qualifications
* Deep understanding of clinical research processes and regulatory requirements.
* Excellent written and verbal communication skills, time management, organizational, and problem-solving abilities.
Education and Experience
* A degree in life sciences or equivalent experience; successful completion of a recognized training program.
* A minimum of four years' experience in clinical research.
Strong attention to detail, excellent analytical skills, and ability to work independently are essential qualities required for this position.