Senior Regional Clinical Research Associate
Corcept Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $125,400 - $178,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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
Requirements
- 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
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial experiencesite monitoringdata query resolutionprotocol adherenceInvestigational Product accountabilityregulatory documentation maintenanceIRB/EC submissionsource data verificationCRF completionSAE reporting
Soft skills
organizational skillstime managementcommunication skillsproblem-solving skillsanalytical skillsleadershipmentoringtrainingcollaborationadaptability
Certifications
Bachelor’s degree in scienceBachelor’s degree in healthcareBachelor’s degree in nursing