Note: The job is a remote job and is open to candidates in USA. Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve outcomes for patients with blood cancer. The Clinical Research Associate will monitor clinical studies at investigative sites or remotely, ensuring trials are conducted, documented, and reported according to protocols, SOPs, ICH-GCP, and regulatory requirements. The role also supports site staff, clinical trial materials, monitoring documentation, and Clinical Operations processes.
Responsibilities
- May serve as the primary monitor and main point of contact for assigned clinical sites
- Conduct interim monitoring visits (IMVs) and ISF review
- Review electronic medical records (EMR)/patient data
- Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
- Provide support to site staff including research coordinators and physicians
- Assist in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides)
- Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates
- Author and submit high-quality monitoring visit reports within required timelines
- Ensure completeness and accuracy of monitoring documentation in the eTMF
Skills
- BA/BS or equivalent with a minimum of 2+ years of CRA experience (for CRA role) or 5+ years with lead monitor responsibilities (Senior CRA)
- Prior CRA experience working directly for sponsor, ideally a start-up/or small company, with primary site ownership and independent monitoring responsibility
- Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
- Experience with Trial Master File management according to the DIA reference model
- Experience operating within various site EMR/EHR systems
- Experience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals, as well as working on trials without a CTMS in place
- Highly detail oriented with special attention to quality and quality control
- Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
- Well organized and able to work under tight deadlines
- Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
- Strong interpersonal skills, including verbal and written communication, are essential
- Ability to work in a collegial and collaborative manner; independently and as part of a team
- Ability to work in a fast-paced and informal startup environment
- Highly tolerant and respectful of all members of our team
- Strong problem-solving skills with desire to improve upon established processes
- Sense of humor
- Therapeutic experience in oncology/hematology and cell and gene therapy preferred
Benefits
- Full-time employment positions will be eligible to receive pre-IPO equity
- Full-time employment positions will be eligible to receive an annual bonus
- Competitive medical, dental, and vision benefits
- PTO
- 401(k) plan
- Life and accidental death and disability coverage
- Parental leave benefits
- Subsidized daily lunches and snacks at our on-site locations
- Remote-based positions
Company Overview
Company H1B Sponsorship