Clinical Research Scientist I

Pivotal Studies

• Review of adjudication charters, endpoint assessment manuals, and related operational plans
• Identification of clinical trial execution risks, operational gaps, and potential barriers to enrollment, data quality, and study delivery
• Assessment of protocol operational feasibility and support for protocol development and pivotal-study planning
• Evaluation of site and vendor performance, including escalation pathways, roles and responsibilities, and operational accountability
• Support for development of risk-mitigation plans, issue-management processes, and corrective and preventive actions, as appropriate

Support Activities

• Cross-functional collaboration with Clinical Development, Clinical Operations, Biometrics, Regulatory, Safety, and external vendors
• Support for regulatory preparation and inspection- or submission-readiness activities

Pay

Pay Range: 150-170/hr