Remote Clinical Research Associate

Summary

The job is for a Clinical Research Associate at Orca Bio, a biotech company specializing in cell therapies for blood cancer patients. The CRA will monitor clinical studies, ensure compliance with regulations, and travel to sites that do not permit virtual monitoring. The role requires 5+ years of relevant experience, oncology/hematology and cell and gene therapy experience preferred, and strong knowledge of FDA and ICH/GCP regulations.

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
• Verification and review of 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 co-monitoring capacity

Benefits

Remote work is possible, although west coast is preferred