Human Subject Protection Specialist

Beacon Hill; Bethesda (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

Beacon Hill is seeking a Clinical Research Ethicist to provide expertise on implementing Human Subjects Protection regulations in clinical research. You will review protocols, consent documents, and related materials to ensure regulatory compliance and ethical integrity.

You will train staff, develop informed consent templates and SOPs, and help digitize processes with IT teams to improve quality and efficiency in projects involving human subjects.

Qualifications

• Excellent writing, interpersonal, critical thinking and attention to detail.
• Working knowledge of the Common Rule and related human subjects regulations.
• Experience in medical writing, IRB activities, site coordination, or regulatory affairs desirable.
• Interest in bioethics or clinical research environment a plus.
• Proficient in Microsoft Office.
• Experience with IT collaboration on digital transformation, AI, data analytics, or process improvement a plus.

Responsibilities

• Act as a Clinical Research Ethicist, providing expertise on implementing human subjects protections in clinical research.
• Regulatory and bioethical reviews of protocols and consent documents for compliance.
• Literature reviews of ethical codes, regulations, and guidance relevant to protection of subjects.
• Train, mentor, and/or supervise staff on regulations application.
• Develop and update informed consent templates, SOPs, and internal guidelines.
• Maintain quality control procedures to ensure timely, high-quality work for clients.
• Support complex projects and client requests related to human subjects protection.
• Assist in evaluating processes and workflows for digitization, automation, AI, and optimization.

Skills

Excellent writing

Interpersonal skills

Critical thinking

Attention to detail

Common Rule knowledge

Ms Office proficiency

IT collaboration

Digital transformation

AI / data analytics awareness

Job description

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.