Senior Regional Clinical Research Associate
Corcept Therapeutics
8 hours ago
Remote friendly (United States)
United States
Clinical Research and Development
Senior Regional Clinical Research Associate (SRCRA)
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 throughout the study
- 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 monitoring plan and SOPs
- Collect and maintain regulatory documentation
- Ensure accurate and timely IRB/EC submission, communication, and approvals are maintained in the Investigator Site File (ISF)
- Reconcile ISF contents with Corcept’s eTMF for completeness/accuracy
- Perform Investigational Product (IP) accountability/reconciliation, document destruction/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 progress and resolve issues
- Assess site readiness and resourcing (personnel, facilities, supplies)
- 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
Preferred Skills, Qualifications, and Technical Proficiencies
- Strong organizational/time management skills; manage multiple priorities and deadlines
- Excellent written/verbal communication; adept in regulatory and clinical terminology
- Proven problem-solving and analytical skills
- Leadership experience mentoring/training junior CRAs
- Proficiency in Microsoft Word, Excel, and 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 of clinical trial experience; at least 4 years as a regional field-based CRA
- Familiarity with ICH-GCP and ability to assess medical data
Compensation
- Pay range: $125,400 - $178,000 (final offer may vary by location and experience)
Application Instructions
- Applicants must be authorized to work in the United States full-time.
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 throughout the study
- 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 monitoring plan and SOPs
- Collect and maintain regulatory documentation
- Ensure accurate and timely IRB/EC submission, communication, and approvals are maintained in the Investigator Site File (ISF)
- Reconcile ISF contents with Corcept’s eTMF for completeness/accuracy
- Perform Investigational Product (IP) accountability/reconciliation, document destruction/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 progress and resolve issues
- Assess site readiness and resourcing (personnel, facilities, supplies)
- 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
Preferred Skills, Qualifications, and Technical Proficiencies
- Strong organizational/time management skills; manage multiple priorities and deadlines
- Excellent written/verbal communication; adept in regulatory and clinical terminology
- Proven problem-solving and analytical skills
- Leadership experience mentoring/training junior CRAs
- Proficiency in Microsoft Word, Excel, and 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 of clinical trial experience; at least 4 years as a regional field-based CRA
- Familiarity with ICH-GCP and ability to assess medical data
Compensation
- Pay range: $125,400 - $178,000 (final offer may vary by location and experience)
Application Instructions
- Applicants must be authorized to work in the United States full-time.