Clinical Research Associate (CRA)
Multi-Site • Full-Time
About the Role
Denali Health is seeking an experienced Clinical Research Associate (CRA) to oversee and monitor clinical trial activities across multiple research sites. This role is essential for ensuring protocol compliance, data integrity, and adherence to regulatory standards throughout the study lifecycle.
Key Responsibilities
- Conduct site qualification, initiation, interim monitoring, and close-out visits
- Verify source data against case report forms for accuracy and completeness
- Ensure sites comply with the study protocol, GCP, and applicable regulations
- Track and manage enrollment metrics, deviations, and corrective actions
- Provide guidance and training to site staff on study-specific procedures
- Prepare and submit visit reports in a timely manner
- Support regulatory inspections and sponsor audits
- Maintain up-to-date knowledge of therapeutic areas and regulatory changes
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field
- 2–5 years of clinical monitoring experience (CRA or equivalent role)
- Thorough knowledge of ICH-GCP guidelines and FDA/Health Canada regulations
- Excellent interpersonal and communication skills
- Ability to travel up to 60% of the time across multiple sites
- Proficiency with CTMS, EDC, and eTMF systems
What We Offer
- Competitive compensation with travel allowance
- Full benefits including health, dental, and vision coverage
- 401(k) with employer matching
- Remote-first flexibility with travel-based site visits
- Access to industry conferences and ongoing professional development