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Quality Assurance and Regulatory Compliance Associate
Durham, NC 27710 United States
The Duke Human Vaccine Institute (DHVI) under the direction of Dr. Barton Haynes, providing national and international leadership in the fight against major infectious diseases, is currently recruiting for a highly motivated individual to join our team. The Duke Human Vaccine Institute is an interdisciplinary, interdepartmental institute dedicated to the study of basic and translational science required to understand host-pathogen interactions that can be translated to vaccines against human diseases. We are a team of highly interactive investigators that have expertise in conducting clinical trials, mucosal and systemic virology, immunology, molecular biology, microbiology and animal models.
The QA & Regulatory Compliance Associate will be responsible for ensuring appropriate Quality and Regulatory Management is applied to all clinical studies conducted by the Duke Vaccine and Trials Unit (DVTU) at the Duke Human Vaccine Institute. In collaboration with Investigators, clinical staff, and administrative teams, this position will develop, implement and oversee quality assurance and regulatory strategies that will span the life of clinical trials including protocol development, start-up, implementation and close-out. Other responsibilities include overseeing the IRB document submission process, implementation of standard operating procedures, data quality management, and liaison with sponsors on submissions of regulatory documents.
The ideal candidate will have a bachelor’s degree in a biological related science field and at least
six years of regulatory/clinical/quality management experience is required. Candidates must have a knowledge of clinical trials guidance documents for the conduct of trials and applicable federal and state laws, statutes and regulations. Experience with Visio, Smartsheet, and Microsoft Project is preferred.
To be considered for the position candidates must apply to requisition 401315976 on the DHVI Careers page and send a cover letter and current CV to:
Duke Human Vaccine Institute
(Please reference “QA-CW” in subject line of email)
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's race, color, religion, age, sex, gender identity, gender expression, sexual orientation, national origin, genetic information, veteran status, or disability.
North Carolina Biotechnology Center