What are the responsibilities and job description for the Human Subject Protection Specialist I position at TECHNICAL RESOURCES INT'L?
Job Description:
Job Requirements:
- Act as a Clinical Research Ethicist, providing expertise on the implementation of relevant Human Subjects Protection regulations in clinical research.
- Conduct 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.
- Carry out literature reviews of ethical codes, regulations, and guidance documents relevant to human subjects' protection in clinical research.
- Train and supervise staff on application of federal regulations.
- Develop, review, and update informed consent templates, SOPs, and internal guidelines to promote high quality work product.
Job Requirements:
- Experience in bioethics or a clinical research environment is a plus.
- Excellent writing, interpersonal skills, critical thinking skills, and detail orientation.
- 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.