Research Compliance Specialist

About the role

The Research Compliance Specialist supports Lehigh Valley Health Network by ensuring that all human subject research complies with federal, state, and institutional regulations. The role involves conducting risk assessments, audits, and providing education to investigators and research staff.

Key responsibilities

• Perform routine and for‑cause compliance audits, maintain audit records, and prepare audit reports for investigators.
• Review and manage research compliance matters, including protocol deviations, conflicts of interest, and allegations of misconduct, and assemble case documentation for committee review.
• Provide training for new investigators on informed consent, regulatory requirements, and source documentation.
• Maintain a tracking system for conflict‑of‑interest disclosures and serve as a resource for investigators.

Required profile

• Bachelor’s degree and at least 2 years of experience in a clinical research environment.
• Ability to work with personnel at all levels, gather information, and communicate compliance requirements.
• Strong attention to detail and adherence to policies and procedures.

Required skills

• Knowledge of FDA, OHRP, DHHS, GCP, and Office of Research Integrity (ORI) regulations.
• Familiarity with AAHRPP requirements and human subjects protection guidelines.