Human Subject Protection Specialist

Position - Human Subject Protection Specialist

Remote Flexibility: Hybrid; 2 days onsite in Bethesda, MD and 3 days remote.

Contract Term: Contract-to-Hire

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 and related documents, including domestic and international sample and site-specific informed consent documents, for compliance with applicable regulations and policies.
• Carry out literature reviews of ethical codes, regulations, and guidance documents relevant to human subjects' protection in clinical research.
• Train, mentor, and/or supervise staff on application of regulations.
• Develop, review, and update informed consent templates, SOPs, and internal guidelines to promote high-quality work products.
• Develop and maintain quality control procedures to ensure appropriate work processes are followed and high-quality and timely work products are delivered appropriately to clients.
• Provide support for complex projects and client requests related to human subjects protection and clinical research.
• Assist in evaluating existing processes and workflows to identify opportunities for digitization, automation, use of AI, and process optimization to ensure compliance with human subjects protection regulations in clinical research, streamline efforts, and enhance quality.

Job Requirements

• Excellent writing, interpersonal skills, critical thinking skills, and attention to detail.
• Working knowledge of the Common Rule and other regulations/policies/guidances relevant to the protection of human subjects in clinical research.
• Experience in medical writing, IRB activities, clinical site coordination, and/or regulatory affairs is highly desirable.
• Experience in/demonstrated interest in bioethics or a clinical research environment is a plus.
• Proficient in Microsoft Office.
• Experience collaborating with IT or technical teams on digital transformation, workflow automation, AI, data analytics, or process-improvement initiatives is a plus.