Lead Site Clinical Research Coordinator, Salma Health
Overview
Own the setup and ongoing operation of Salma Health's Fremont clinic research site at scale, coordinating ATLAS and sponsored trials under PI supervision. Build compliant research operations and serve as primary contact for sponsors, IRB, and participants. Grow the team as the site portfolio expands.
What You'll Do10
- 1Build and stand up Fremont clinic research operations for ATLAS and sponsored trials to activation
- 2Coordinate study management tasks from startup through closeout ensuring regulatory and GCP compliance
- 3Engage sponsors and vendors, respond to feasibility questionnaires, and support site qualification
- 4Prepare IRB submissions, amendments, and adverse event reports and maintain essential regulatory documents
- 5Manage data collection and source documentation in EDC systems like REDCap or Medidata Rave
- 6Schedule and conduct participant visits, obtain consent, and ensure protocol adherence
- 7Identify and report adverse events and protocol deviations to PI and IRB
- 8Support regulatory submissions across multiple Salma Health sites and maintain DOA and training logs
- 9Mentor junior staff and coordinate cross-site regulatory activities as the site grows
- 10Communicate status and issues to PI and leadership while ensuring retention and collaboration
Requirements6
- 1Bachelor’s degree in a health science or related field
- 2Minimum 3 years of clinical research experience
- 3Strong regulatory background with IRB and sponsor submissions
- 4Willingness to perform phlebotomy or obtain certification
- 5Ability to travel up to 25 across sites
- 6Experience with REDCap or Medidata Rave is a plus
Salary Insight
$72 - $100k per year
Location
Required Skills
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