Summary
The Senior CRA will be responsible for monitoring clinical trials for Orca Bio's phase 3 Precision-T study, either on-site or remotely. The role requires a minimum of 5 years of relevant experience in clinical trial management, with therapeutic experience in oncology/hematology and cell and gene therapy preferred. The position offers pre-IPO equity, medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, parental leave benefits, free daily lunches and snacks at on-site locations.
Requirements
BA/BS or equivalent with a minimum of 5+ years of relevant clinical trial management experience
Responsibilities
- Conduct interim monitoring visits (IMVs) and ISF review
- Review electronic medical records (EMR)/patient data
- Source documentation verification (SDV) against case report form data
- Verify and review adverse events, serious adverse events, concomitant medications and corresponding illnesses
- Provide support to site staff including research coordinators and physicians
- Assist in the development of trial materials as needed
- Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates
Preferred Qualifications
- Therapeutic experience in oncology/hematology and cell and gene therapy
- Prior CRA experience working directly for sponsor, ideally a start-up/or small company, in a leading and co-monitoring capacity
Benefits
- Pre-IPO equity
- Medical, dental, and vision benefits
- Flexible PTO
- 401(k) plan
- Life and accidental death and disability coverage
- Parental leave benefits
- Free daily lunches and snacks at on-site locations
