Human Subjects Protection Specialist
Company: Technical Resources International
Location: Bethesda
Posted on: January 12, 2021
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Job Description:
Responsibilities: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.Requirements: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.
Keywords: Technical Resources International, Bethesda , Human Subjects Protection Specialist, Other , Bethesda, Maryland
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