Remote Senior Clinical Research Associate

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