Regulatory Operations Manager
1 week ago
Senior Regulatory Coordinator Role
Job Summary:
We are seeking a highly skilled Senior Regulatory Coordinator to lead the regulatory and safety operations of a team conducting oncology clinical trials and research studies for our Cancer Institute's Clinical Research Program at Duke Health.
Key Responsibilities:
- Oversee day-to-day regulatory operations for multiple oncology clinical trials, ensuring compliance with institutional requirements and policies.
- Develop and implement Standard Operating Procedures (SOPs) for research programs, ensuring adherence to regulatory guidelines.
- Manage resources, including staff, supplies, and equipment, to support research program operations.
- Prepare and lead research program meetings, facilitating collaboration and communication among team members.
- Oversee the development and submission of regulatory documents to Institutional Review Boards (IRBs), ensuring timely and accurate submissions.
- Ensure study compliance with institutional requirements, protocols, and regulatory guidelines.
Qualifications:
- Bachelor's degree in a related field, such as life sciences, healthcare administration, or a related field.
- Minimum of six years of experience in research and/or regulatory affairs, with a focus on oncology or research.
- Proven experience in developing and implementing SOPs, managing resources, and ensuring compliance with regulatory guidelines.
About Duke Health:
Duke Health is a world-class academic medical center dedicated to improving human health globally. Our team of researchers, physicians, and staff work together to accelerate scientific discoveries that impact cancer care. As a Senior Regulatory Coordinator at Duke Health, you will be part of a dynamic team committed to delivering exceptional cancer care to our community and beyond.
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