Senior Regional Clinical Research Associate

About the role

Corcept is headquartered in Redwood City, California. The Senior Regional Clinical Research Associate (SRCRA) serves as the primary liaison to clinical trial sites participating in Corcept-sponsored studies. This role is responsible for managing 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

• 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
• 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
• 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

Qualifications

• Bachelor's degree in science, healthcare, or nursing
• 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
• In-depth knowledge of FDA regulations and industry practices
• 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
• Willingness to travel up to 80% regionally, with occasional cross-country travel

Pay

$125,300 – $165,800; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.