IRB & Human Subjects 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 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.