This position will act as a Clinical Research Ethicist, providing expertise on the implementation of relevant Human Subjects Protection regulations in clinical research. Responsibilities include conducting regulatory and bioethical reviews of clinical trial protocols, including domestic and international sample and site-specific informed consent documents, for compliance with applicable federal regulations and policies; conducting literature reviews of ethical codes, regulations, and guidance documents relevant to human subjects protection in clinical research; training and supervising staff on application of federal regulations; developing, reviewing, and updating informed consent templates, SOPs and internal guidelines to promote high quality work product.
A relevant Ph.D. or a master's degree with at least 2 years of experience in bioethics or a clinical research environment, and excellent writing and interpersonal skills. The ideal candidate will have a working knowledge of the Common Rule and other regulations/policies relevant to the protection of human subjects. Experience in medical writing, IRB activities, infectious diseases, working with HIV patients, and/or regulatory affairs is highly desirable.
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