Senior Regional Clinical Research Associate

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November 13

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Corcept Therapeutics

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Biotechnology • Pharmaceuticals • Science

Corcept Therapeutics is a biopharmaceutical company focused on unlocking the potential of cortisol modulation to revolutionize the treatment of serious diseases. The company is dedicated to understanding and modulating cortisol activity at the glucocorticoid receptor to develop novel treatments for severe disorders. With more than 30 ongoing studies, Corcept is building a scientific foundation to deliver new approaches in fields such as endocrinology, oncology, metabolism, and neurology. The company aims to bring innovative therapies to patients by exploring new possibilities in cortisol modulation science.

201 - 500 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $525.3k Post-IPO Equity on 2012-04

📋 Description

• 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.