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.
- 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 on the progress, approval, and execution of required documents.
Qualifications
- Based in Argentina or Brazil.
- Bachelor's Degree in Life Sciences or a related field required.
- 1-3 years of clinical research experience supporting site activation/regulatory tasks.
- Advanced level of English.