Senior Regional Clinical Research Associate

6+ years of clinical trial experience At least 4 years as a regional field-based CRA Bachelor’s degree in science, healthcare, or nursing (preferred) Familiarity with ICH-GCP guidelines Ability to assess medical data Strong organizational and time management skills Excellent written and verbal communication skills 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

Conduct qualification, initiation, interim, and close-out visits remotely and on-site Act as the main point of contact for site staff and ensure consistent communication Monitor site performance including recruitment, enrollment, source data verification, protocol adherence, safety reporting, and data query resolution Train site staff on protocol requirements, source documentation, and CRF completion Prepare and submit visit reports and correspondence Responsible for the collection and maintenance of regulatory documentation Ensure accurate and timely IRB/EC submission, communication, and approvals are maintained Reconcile ISF contents with Corcept’s eTMF Responsible for Investigational Product (IP) accountability and reconciliation Ensure timely and appropriate SAE reporting and submission to IRBs Draft and deliver confirmation, follow-up, and monitoring visit reports Maintain regular communication with the Lead RCRA Assess site readiness and resourcing Collaborate with vendors to resolve operational issues Lead or participate in co-monitoring, oversight, and training visits