Senior Regional Clinical Research Associate

Role Summary

The Senior Regional Clinical Research Associate (SRCRA) serves as the primary liaison to clinical trial sites participating in Corcept-sponsored studies. This role is responsible for managing site activities across all stages—qualification, initiation, monitoring, and close-out. The SRCRA ensures patient recruitment, enrollment, and overall site performance are aligned with GCP, ICH guidelines, and Corcept SOPs.

Responsibilities

• 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

Qualifications

• 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

Skills

• Regulatory and clinical terminology proficiency
• Communication and interpersonal skills for site engagement
• Problem-solving and analytical thinking
• Leadership and mentoring capabilities
• Microsoft Word, Excel, and PowerPoint proficiency
• Knowledge of FDA regulations and industry best practices
• Ability to travel as required

Education

• 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