Job Summary
A company is looking for an Oncology Research Coordinator in Regulatory Affairs & Compliance.
Key Responsibilities
- Manages regulatory submissions and documentation for clinical trials, including consent and protocol amendments
- Liaises with various stakeholders on clinical trial regulatory operations and oversees timely submissions
- Coordinates audits and provides educational support to research staff on regulatory compliance
Required Qualifications, Training, and Education
- Bachelor's Degree with 1 year of clinical research experience, or a Master's Degree with 0-1 year of experience, or 3 years of relevant experience without a degree
- Health/Science degree preferred
- Previous experience in a healthcare setting, especially in cancer care or clinical research, is preferred
- Certification in clinical research (SoCRA, ACRP, RAPS, etc.) is preferred
- Regulatory knowledge of FDA/OHRP regulations is required
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