Senior Regional Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the main liaison for clinical trial sites involved in Corcept-sponsored studies.

• Oversee site operations throughout the qualification, initiation, monitoring, and close-out phases.

• Perform qualification, initiation, interim, and close-out visits both remotely and on-site.

• Serve as the primary contact for site personnel and sustain study-related communications.

• Supervise recruitment, enrollment, source data verification, protocol compliance, safety reporting, data inquiries, and site performance.

• Meet with Principal Investigators to review findings and outline subsequent steps.

• Provide training to site staff on protocols, source documentation, and CRF completion.

• Prepare and submit reports and correspondence in accordance with monitoring plans and SOPs.

• Gather and manage regulatory documentation.

• Handle IRB/EC submissions, approvals, Investigator Site Files, eTMF reconciliation, investigational product accountability, and SAE reporting.

• Draft confirmation, follow-up, and monitoring visit reports.

• Update the Lead RCRA on site progress and address any issues.

• Evaluate site readiness and resource allocation.

• Collaborate with vendors to troubleshoot operational challenges.

• Lead or take part in co-monitoring, oversight, and training visits.

⛳️ Requirements

• Strong organizational and time management abilities; adept at managing multiple priorities and deadlines.

• Excellent written and verbal communication skills, particularly with regulatory and clinical terminology.

• Demonstrated problem-solving and analytical capabilities.

• Leadership experience in mentoring and training junior CRAs.

• Proficiency in Microsoft Word, Excel, and PowerPoint.

• Comprehensive understanding of FDA regulations and industry standards.

• Willingness to travel up to 80% regionally, with some occasional cross-country travel.

• Bachelor’s degree in science, healthcare, or nursing (preferred).

• Over 6 years of clinical trial experience, including at least 4 years as a regional field-based CRA (preferred).

• Familiarity with ICH-GCP guidelines and the ability to evaluate medical data.

• Must currently be authorized to work in the United States on a full-time basis.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Retirement savings plan with company match.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and advancement.

• Flexible working arrangements.