Senior Regional Clinical Research Associate

Responsibilities:
- Conduct qualification, initiation, interim, and close-out visits (remote and on-site)
- Serve as main point of contact for site staff and ensure consistent communication
- Monitor site performance: recruitment, enrollment, source data verification, protocol adherence, safety reporting, and data query resolution
- Meet with the Principal Investigator during visits to discuss findings and next steps
- Train site staff on protocol requirements, source documentation, and CRF completion
- Prepare and submit visit reports and correspondence per the monitoring plan and SOPs
- Collect and maintain regulatory documentation
- Ensure accurate and timely IRB/EC submissions, communication, and approvals in the Investigator Site File (ISF)
- Reconcile ISF contents with Corcept’s eTMF for completeness and accuracy
- Conduct Investigational Product (IP) accountability/reconciliation, document destruction and return, and monitor re-supply and storage conditions
- Ensure timely and appropriate SAE reporting to IRBs
- Draft confirmation/follow-up/monitoring visit reports (SQV, SIV, IMV, COV)
- Maintain regular communication with the Lead RCRA (LRCRA) to report progress and resolve issues
- Assess site readiness and resourcing; collaborate with vendors (e.g., central lab, imaging core)
- Lead or participate in co-monitoring, oversight, and training visits as needed

Preferred Skills, Qualifications, and Technical Proficiencies:
- Strong organizational/time management; manages multiple priorities and deadlines
- Excellent written/verbal communication; regulatory and clinical terminology
- Proven problem-solving and analytical skills
- Leadership experience mentoring/training junior CRAs
- Proficient in Microsoft Word, Excel, PowerPoint
- In-depth knowledge of FDA regulations and industry practices
- Travel up to 80% regionally (occasional cross-country)

Preferred Education and Experience:
- Bachelor’s degree in science, healthcare, or nursing
- 6+ years clinical trial experience; at least 4 years as a regional field-based CRA
- Familiarity with ICH-GCP; ability to assess medical data

Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.