What are the responsibilities and job description for the Human Subject Protection Specialist I position at Technical Resources International, Inc.?
Location
Bethesda, MD 20817 US (Primary)
Category
Medical Writing
Job Type
Full-Time
Salary Range
65000-85000.00/YEAR
Education
Bachelor's Degree
Travel
None
Job Description
- 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.
We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.