Senior Regional Clinical Research Associate

Role Summary

The Senior Regional Clinical Research Associate 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—and ensures patient recruitment, enrollment, and site performance align 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 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

• 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

Skills

• Strong organizational and time management
• Excellent written and verbal communication
• Problem-solving and analytical abilities
• Leadership and mentoring capabilities
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Familiarity with regulatory and clinical terminology
• Knowledge of FDA regulations and industry practices

Education

• 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

Additional Requirements

• Willingness to travel up to 80% regionally, with occasional cross-country travel