Clinical Trial Assistant

Summary

Join Orca Bio, a late-stage biotechnology company revolutionizing blood cancer treatment, as a Clinical Trial Assistant (CTA). You will play a crucial role in supporting clinical trial operations, working closely with clinical research teams to ensure site readiness, maintain data quality, and facilitate effective communication. This position involves collaborating with cross-functional teams, updating clinical trial management systems (CTMS), and conducting follow-up on action items. The ideal candidate possesses prior experience as an in-house CTA or equivalent role, strong organizational and communication skills, and the ability to work independently. Orca Bio offers a dynamic and supportive work environment driven by a passion for science and compassion for patients.

Requirements

• Previous experience as an in-house CTA CRA or equivalent clinical trial support role is required
• Strong organizational and critical thinking skills
• Ability to work independently and take initiative with minimal supervision
• Ability to quickly understand and apply instructions from the Clinical Trial Manager (CTM)
• Willingness to participate in occasional site monitoring visits (virtual or in-person, approximately every quarter other month)
• Excellent communication skills for effective coordination and follow-up with sites and internal teams

Responsibilities

• Assist site CRAs in preparing for site visits and ensure sites are ready for monitoring
• Support sites in maintaining high-quality data entry and tracking progress
• Collaborate with data management to identify key areas of focus for sites and CRAs
• Update CTMS and other relevant systems post-site visits, logging necessary data, including deviations and visit details
• Ensure accurate and timely updates to all relevant trial documentation
• Conduct follow-up on action items from site visits to ensure timely resolution and completion
• Manage site management calls, generate minutes, and provide updates on outstanding items
• Assist in compiling baseline information for progress reports
• Maintain and update various clinical trial systems, databases, study trackers, and documentation
• Support the set up and maintenance of the trial master file (TMF)
• Assist with the preparation and submission of clinical trial-related materials as needed

Preferred Qualifications

• Prior experience as a CRCRA is preferred but not mandatory
• Experience with CTMS and other clinical trial management systems and TMF systems is a plus
• Experience in Hematology/Oncology (HemOnc) or cell therapies is desired but not required