Site Activation Specialist
1 week ago
Job Overview
Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, standard operating procedures (SOPs), and project requirements at the regional or country level.
Key Responsibilities
- Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors.
- Maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites.
- Tracks completion of appropriate documents for sites; ensures contracts are fully executed.
- Establishes project timelines and coordinates with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.
Essential Functions
- With moderate oversight and supervision, serves as a Single Point of Contact (SPOC) to perform feasibility, site activation, and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs, and work instructions.
- Reviews documents for completeness, consistency, and accuracy, under guidance of senior staff.
- Prepares site documents, reviewing for completeness and accuracy.
- Updates and maintains internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project-specific information.
- Reviews, tracks, and follows up the progress, approval, and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents.
Qualifications
- Bachelor's Degree in Life Sciences or a related field.
- 1-3 years' clinical research or other relevant experience; or equivalent combination of education, training, and experience.
- Advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
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