Human Subject Protection Specialist - Clinical Research
Founded in 1979, Technical Resources International, Inc. (TRI) is a full-service contract research organization plus (CRO+) providing product development support services to the global drug, biologic, and medical device community through the effective combination of scientific, clinical information technology, and communications services. TRI, Inc. is currently seeking a Human Subject Protection Specialist to join our Bethesda team.
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 include a relevant PhD 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.
Submit resume and salary requirements to: Attn: EH, TRI, 6500 Rock Spring Drive, Suite 650, Bethesda, MD 20817, or fax to (301) 897-1702, or email to HR@tech-res.com.
Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.