Corcept is seeking a Senior Regional Clinical Research Associate (SRCRA) to serve as the primary liaison to clinical trial sites, ensuring patient recruitment, enrollment, and overall site performance align with GCP, ICH guidelines, and Corcept SOPs for their ongoing studies in endocrinology, oncology, metabolism, and neurology.
Requirements
- In-depth knowledge of FDA regulations and industry practices
- Familiarity with ICH-GCP guidelines and the ability to assess medical data
Responsibilities
- Conduct qualification, initiation, interim, and close-out visits both remotely and on-site
- Monitor site performance, including recruitment, enrollment, source data verification, protocol adherence, safety reporting, and data query resolution
- Train site staff on protocol requirements, source documentation, and CRF completion
- Prepare and submit visit reports and correspondence in accordance with the monitoring plan and SOPs
- Ensure accurate and timely IRB/EC submission, communication, and approvals are maintained within the Investigator Site File (ISF)
- Reconcile ISF contents with Corcept’s eTMF to ensure completeness and accuracy
- Responsible for conducting Investigational Product (IP) accountability and reconciliation, document destruction and return, and monitor re-supply and storage conditions
Other
- Act as the main point of contact for site staff and ensure consistent communication throughout the study
- Meet with the Principal Investigator during visits to discuss findings and next steps
- Strong organizational and time management skills; capable of managing multiple priorities and deadlines
- Excellent written and verbal communication skills; adept in regulatory and clinical terminology
- Proven problem-solving and analytical skills
- Leadership experience with the ability to mentor and train junior CRAs
- Willingness to travel up to 80% regionally, with occasional cross-country travel
