- Lead the end-to-end screening process, ensuring all pre-procedure assessments (e.g., CT, echo, labs, risk scoring) are completed accurately and on time across participating sites.
- Lead scientific and operational evaluation of inclusion/exclusion criteria, providing clear, defensible decisions on subject eligibility in alignment with the protocol and regulatory expectations.
- Partner with investigators, coordinators, and field teams to drive screening performance, troubleshoot barriers, and ensure consistent application of screening criteria.
- Collaborate with cardiologists, study coordinators, and clinical teams to prioritize potential participants.
- Provide clinical insights to support case planning and feasibility discussions.
- Ensure compliance with GCP, FDA, and trial protocols during all screening activities.
- Lead live screening meetings to review cases and discuss patient eligibility trends.
- Ensure completeness, accuracy, and protocol compliance of all screening-related data; identify trends, gaps, and risks requiring corrective action.
GCP