Human Subject Protection Specialist

Technical Resources International, Inc.; Bethesda (MD); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Technical Resources International, Inc. seeks a Clinical Research Ethicist to provide expertise on applying Human Subjects Protection regulations in clinical research. The role includes reviewing protocols and consent documents for regulatory compliance, performing literature reviews, and training staff.

It is a hybrid position with 2 days in TRI's Bethesda, Maryland office and 3 days remote. Experience with the Common Rule, IRB activities, and bioethics in clinical research is highly desirable;

Qualifications

• Excellent writing, interpersonal, critical thinking, and attention to detail.
• Working knowledge of the Common Rule and related human subjects protections.
• Experience in medical writing, IRB activities, and regulatory affairs is highly desirable.
• Experience with 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.

Responsibilities

• 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 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.

Skills

Writing

Interpersonal skills

Critical thinking

Attention to detail

Microsoft Office

Digital transformation

Workflow automation

AI analytics

Tools

Microsoft Office

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.
• This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.