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Responsibilities:
- Monitor clinical trial sites, conduct interim monitoring visits, and review electronic medical records.
- Ensure compliance with protocols, GCP, and regulatory requirements.
- Support site staff and contribute to development of trial materials, SOPs, and training guides.
Qualifications:
- BA/BS or equivalent with 2+ years of CRA experience (or 5+ for senior) with oncology/hematology experience preferred.
- Strong knowledge of FDA and ICH/GCP regulations, experience with eTMF, EDC, and CTMS.
- Detail-oriented, able to multitask, and work in a fast-paced startup environment.
Benefits:
- Competitive salary, pre-IPO equity, and annual bonus.
- Comprehensive benefits including medical, dental, vision, PTO, 401(k), and parental leave.
- Start-up culture with opportunities for growth.
Orca Bio
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.