Human Subject Protection Specialist

Piper Companies; Bethesda (MD); Hybrid; USD 40,000 - 50,000; Full time

Job summary

Piper Companies seeks a Human Subject Protection Specialist to join a clinical research organization supporting federal programs in Bethesda, MD. The role focuses on regulatory and ethical review of protocols, consent documents, and related materials to ensure compliance with HSP standards.

You'll develop consent templates, SOPs, and guidance documents, and support client projects on clinical research compliance and process improvements, leveraging expertise in the Common Rule and IRB activities.

Qualifications

• Bachelor's degree in a scientific, healthcare, or related field.
• Experience in medical, scientific, regulatory writing or IRB activities.
• Knowledge of Common Rule (45 CFR 46) and informed consent requirements.

Responsibilities

• Review protocols, consent documents for regulatory and ethical compliance.
• Assess regulatory guidance and policies for human subjects protection.
• Develop and maintain consent templates, SOPs, and guidance documents.
• Support client projects on human subjects protection and regulatory compliance.
• Provide subject matter expertise on HSP regulations.

Skills

HSP regulations knowledge

Regulatory compliance

IRB coordination

Education

Bachelor's degree in a scientific/healthcare field

Tools

Microsoft Office

Job description

Piper Companies is seeking a Human Subject Protection Specialist to join a clinical research organization supporting federal research programs in Bethesda, MD.

Responsibilities of the Human Subject Protection Specialist include:

• Provide subject matter expertise on Human Subjects Protection (HSP) regulations and their application within clinical research.
• Review clinical trial protocols, informed consent documents, and related research materials for regulatory and ethical compliance.
• Conduct reviews of regulations, ethical guidance, and policies related to the protection of human subjects in research.
• Develop and maintain informed consent templates, SOPs, internal guidance documents, and quality control procedures.
• Support client projects related to human subjects protection, clinical research compliance, and process improvement initiatives.

Qualifications for the Human Subject Protection Specialist include:

• Bachelor's degree in a scientific, healthcare, clinical research, or related field.
• Experience in medical writing, scientific writing, regulatory writing, IRB activities, clinical site coordination, research documentation, regulatory affairs, or clinical research compliance.
• Working knowledge of Human Subjects Protection regulations, including the Common Rule (45 CFR 46), informed consent requirements, and related clinical research regulations.
• Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
• Experience within a clinical research, healthcare, hospital, academic medical center, or research institution environment preferred.

Compensation for the Human Subject Protection Specialist includes:

• Salary Range: $28.80 - $36.06/hr, depending on experience
• Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law

This job is open for applications on October 20th, 2026. Applications will be accepted for at least 30 days from the posting date.

Keywords: Human Subject Protection Specialist, Human Subjects Protection, Clinical Research, Clinical Research Coordinator, Clinical Research Specialist, IRB Coordinator, IRB Specialist, Research Compliance Specialist, Regulatory Affairs Specialist, Clinical Regulatory Specialist, Medical Writer, Scientific Writer, Clinical Research Writer, Regulatory Medical Writer, Research Documentation Specialist, Research Ethics, Bioethics, Common Rule, Informed Consent, Clinical Trials, Research Compliance, Clinical Research Compliance

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