Human Subject Protection Specialist

Technical Resources International, Inc.; North Bethesda (MD); Hybrid; USD 75,000 - 85,000; Full time

Job summary

Technical Resources International, Inc. is seeking a Hybrid Human Subject Protection Specialist in Bethesda, MD. The role focuses on applying regulatory knowledge to protect human subjects in clinical research, including ethics reviews and documentation updates.

The position requires a Bachelor's degree, strong writing skills, and experience with IRB activities or regulatory affairs. Collaboration with IT and teams on process improvements is a plus, with two days in-office and three days remote.

Qualifications

• Excellent writing and interpersonal skills are essential.
• Strong knowledge of the Common Rule and related regulations.
• Experience in medical writing, IRB activities, clinical site coordination, or regulatory affairs is highly desirable.

Responsibilities

• Act as a Clinical Research Ethicist and advise on Human Subjects Protection regulations in clinical research.
• Conduct regulatory and bioethical reviews of trial protocols and related documents for compliance.
• Perform literature reviews of ethical codes, regulations, and guidance in human subjects protection.
• Train or supervise staff on application of regulations.
• Develop and update informed consent templates, SOPs, and internal guidelines.
• Establish and maintain QC procedures to ensure quality and timely deliverables for clients.
• Provide support for complex projects and client requests in human subjects protection and clinical research.
• Assist in evaluating processes and workflows for digitization, automation, AI, and process optimization.

Skills

Excellent writing

Interpersonal skills

Critical thinking

Attention to detail

Regulatory knowledge

IT/digital transformation awareness

Education

Bachelor's Degree

Tools

Microsoft Office

Job description

Human Subject Protection Specialist - (HSP001_COMPANY_1.2)

Job Title

Human Subject Protection Specialist

Location

Bethesda, MD 20817 US (Primary)

Category

Medical Writing

Job Type

Full-Time

Salary Range

$75,000-$85,000

Education

Bachelor's Degree

Travel

None

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.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.