Senior Regional Clinical Research Associate

Role Summary

The Senior Regional Clinical Research Associate (SRCRA) serves as the primary liaison to clinical trial sites participating in Corcept-sponsored studies. This role manages site activities across all stages—qualification, initiation, monitoring, and close-out. The SRCRA ensures patient recruitment, enrollment, and overall site performance are aligned with GCP, ICH guidelines, and Corcept SOPs.

Responsibilities

• Site Monitoring & Oversight: Conduct qualification, initiation, interim, and close-out visits both remotely and on-site
• Act as the main point of contact for site staff and ensure consistent communication throughout the study
• Monitor site performance, including 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 in accordance with the monitoring plan and SOPs

Regulatory and Documentation Compliance

• Responsible for the collection and maintenance of regulatory documentation
• 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
• Ensure timely and appropriate SAE reporting and submission to IRBs

Site Communications & Relationship Management

• Draft and deliver confirmation, follow-up, and monitoring visit reports (SQV, SIV, IMV, COV)
• Maintain regular communication with the Lead RCRA (LRCRA) to report on site progress and resolve issues
• Assess site readiness and resourcing (personnel, facilities, supplies) for trial conduct
• Collaborate with vendors (e.g., central lab, imaging core) to resolve operational issues
• Lead or participate in co-monitoring, oversight, and training visits as needed

Skills

• 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
• Proficiency in Microsoft Word, Excel, and PowerPoint
• In-depth knowledge of FDA regulations and industry practices
• Willingness to travel up to 80% regionally, with occasional cross-country travel

Education

• Bachelor’s degree in science, healthcare, or nursing

Qualifications

• 6+ years of clinical trial experience, including at least 4 years as a regional field-based CRA
• Familiarity with ICH-GCP guidelines and the ability to assess medical data