Senior Regional Clinical Research Associate

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🔥 27 minutes ago

🇺🇸 United States – Remote

💵 $125.3k - $165.8k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Corcept Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1997

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $525.3k Post-IPO Equity on 2012-04

Healthcare • Biotechnology • Pharmaceuticals

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.

📋 Description

• Serve as the primary liaison to clinical trial sites participating in Corcept-sponsored studies • Manage site activities across qualification, initiation, monitoring, and close-out • Conduct qualification, initiation, interim, and close-out visits remotely and on-site • Act as the main point of contact for site staff and maintain study communications • Monitor recruitment, enrollment, source data verification, protocol adherence, safety reporting, data queries, and site performance • Meet with Principal Investigators to discuss findings and next steps • Train site staff on protocols, source documentation, and CRF completion • Prepare and submit visit reports and correspondence according to monitoring plans and SOPs • Collect and maintain regulatory documentation • Manage IRB/EC submissions, approvals, Investigator Site Files, eTMF reconciliation, investigational product accountability, and SAE reporting • Draft confirmation, follow-up, and monitoring visit reports • Report site progress to the Lead RCRA and resolve issues • Assess site readiness and resourcing • Collaborate with vendors to resolve operational issues • Lead or participate in co-monitoring, oversight, and training visits

🎯 Requirements

• Strong organizational and time management skills; ability to manage multiple priorities and deadlines • Excellent written and verbal communication skills with regulatory and clinical terminology • Proven problem-solving and analytical skills • Leadership experience mentoring and training 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 • Bachelor’s degree in science, healthcare, or nursing (preferred) • 6+ years of clinical trial experience, including at least 4 years as a regional field-based CRA (preferred) • Familiarity with ICH-GCP guidelines and ability to assess medical data • Must be currently authorized to work in the United States on a full-time basis