Description
Under moderate supervision, you will execute feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level.
You will prepare and manage site documentation, review and negotiate site documents and contracts with sites and sponsors, maintain, review, and report on site performance metrics, and serve as the primary point of contact for investigative sites.
Essential Functions
- Serve 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, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Prepare site documents, reviewing for completeness and accuracy.
- Inform team members of completion of regulatory, contractual, and other documents for individual sites.
- Distribute completed documents to sites and internal project team members.
- Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
- Review, track and follow up the progress, the 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.
- 3 years' experience in a healthcare environment or equivalent combination of education, training and experience.