Program Manager, Research Compliance

Overview
The Research Compliance Specialist will support research compliance and policy needs with a strong emphasis on standards of integrity and ethics. This role will be responsible for developing, implementing, and monitoring compliance policies and procedures, providing guidance and training to researchers, and overseeing external audit readiness. The position reports to departmental leadership.

Responsibilities

Program Administration : Provides research compliance program administration by interpreting and applying research compliance rules and regulations for the university, its community, research sponsors, and regulatory entities. Promotes best practices, quality improvement, and institutional compliance with sponsoring agency obligations. Organizes data, extracts information, and helps prepare reports for the Director. Maintains and enhances existing procedures and training that support the department’s compliance programs and guidelines.

Policy Implementation : Conducts regular audits and inspections, identifies and resolves instances of non‑compliance, and mitigates risks. Leads the internal auditing team to ensure external audit readiness. Serves as the primary liaison for any external audit from a sponsor or regulatory entity. Collaborates with Legal, IRB, and the Clinical Operations Team to coordinate audits and align institutional processes.

Provides guidance and educational opportunities to research faculty, staff, and students concerning research regulations, compliance, and procedures. Serves as a trusted liaison between organizations and regulatory agencies. Performs all other duties as assigned.

Licenses and Certifications
None.

Minimum Education and Experience Requirements

Bachelor’s degree in a relevant field such as biology, public health, or regulatory affairs.

Minimum 3‑5 years of experience in a regulatory affairs role.

Preferred Education and Experience
Experience in academic research is highly preferred.

Required Knowledge, Skills, and Abilities

Familiarity with regulatory agencies and bodies.

Strong organizational, leadership, and cross‑cultural communication skills.

Working Conditions
Normal office environment with little exposure to excessive noise, dust, temperature, and the like.

Physical Requirements
Not specified.

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