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Regulatory Coordinator, Duke Cancer Institute
2 months ago
We are seeking a highly skilled Regulatory Coordinator to join our team at Duke University School of Medicine. The successful candidate will be responsible for performing regulatory and safety processes for multiple, complex oncology clinical trials and research studies.
Key Responsibilities- Develop and submit Institutional Review Board (IRB) documents, including consent forms, protocols, and continuing reviews.
- Maintain study level documentation, including regulatory binders, enrollment logs, and patient registration in the system of record.
- Provide regulatory and safety reports, and ensure compliance with institutional requirements, protocols, and other applicable policies.
- Oversee the maintenance of Delegation of Authority Logs and training of key personnel on study-specific duties.
- Collaborate with study sponsors on regulatory and safety issues, and prepare for study monitoring and audit visits.
- Complete and submit Adverse Events Reports, according to institution and sponsor-specific reporting requirements.
- Minimum of two years of research and/or regulatory experience.
- Associate's degree or Bachelor's degree may substitute for 2 years of required experience.
- Strong communication and interpersonal skills, with ability to work effectively in a team environment.
- Ability to maintain confidentiality and handle sensitive information.
- Oncology or research experience, training, or education.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes.
