Senior Regional Clinical Research Associate
Skills
- Strong organizational and time-management skills for managing multiple priorities
- Excellent written and verbal communication and regulatory terminology proficiency
- Proven problem-solving and analytical capabilities
- Leadership experience with ability to mentor and train junior CRAs
- Proficiency with Microsoft Word, Excel, and PowerPoint
- In-depth knowledge of FDA regulations, ICH-GCP, and industry best practices
- Ability and willingness to travel regionally up to 80% (occasional cross-country travel)
- Self-motivated and able to work independently in a remote environment
Responsibilities
- Conduct qualification, initiation, interim, and close-out visits both remotely and on-site
- Serve as primary contact for site staff and maintain consistent study communication
- Monitor recruitment, enrollment, source data verification (SDV), protocol adherence, safety reporting, and data query resolution
- Meet with Principal Investigators during visits to review findings and next steps
- Train site staff on protocol requirements, source documentation, and CRF completion
- Prepare and submit visit reports and study correspondence per monitoring plan and SOPs
- Collect, maintain, and reconcile regulatory documentation in the Investigator Site File (ISF)
- Ensure timely IRB/EC submissions and approvals and reconcile ISF with the eTMF
- Perform Investigational Product (IP) accountability, reconciliation, destruction/return as required
- Ensure timely SAE reporting and regulatory submissions
- Assess site readiness and resourcing, and collaborate with vendors (central lab, imaging core) to resolve operational issues
- Maintain regular communication with Lead RCRA and escalate/resolving site issues
- Lead or participate in co-monitoring, oversight, and training visits as needed
Education
- Bachelor’s degree in science, healthcare, nursing, or related field (required)
- Minimum 6 years of clinical trial experience, including at least 4 years as a field-based CRA
- Familiarity with ICH-GCP guidelines and ability to assess medical data
- Authorization to work in the United States full-time (required)
Benefits
- Comprehensive medical, dental, and vision insurance
- 401(k) retirement plan with company match
- Paid time off and paid holidays
- Remote work flexibility
- Professional development and training opportunities
- Travel reimbursement for business travel
- Competitive salary and potential performance-based compensation
Average salary estimate
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