Human Subjects Protection Specialist

Industry

Science and Research

Advert ID

USA_450122

Location

Bethesda

Job Type

Permanent

Hours

Full-Time

Salary Range

USD48000-55000 per year

No. of Openings

1

Branch Information

Bethesda, MD - (USA) 4800 Hampden Lane Suite 200 MD Bethesda , MD - 20814 Phone : 301-215-6346

ContactNumber

301-215-6346

Job Description

HUMAN SUBJECTS PROTECTION SPECIALIST ( up to 5 positions)

Salary range - $48K to $55K depending on experience



RESPONSIBILITIES

This position will act as a Clinical Research Ethicist, providing expertise on the implementation of relevant Human Subjects Protection regulations in clinical research.

*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

*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.

*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. (FYI - if infectious diseases are not on resume, working with HIV patients on their resume, oncology & hepatitis experience on someone's resume is excellent experience and a candidate they would definitely consider).