Program Manager, Research Compliance

Essential Duties and Responsibilities

• Provides research compliance program administration by interpreting and applying research compliance rules and regulations for the university and 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.
• Conducts regular audits and inspections to identify and resolve any instances of non-compliance and mitigate risks.
• Serves as the primary liaison for any external audit from an external sponsor or other external regulatory entity.
• Collaborates with Legal, IRB, and the Clinical Operations Team to ensure audit coordination and institutional alignment.
• Develops and implements comprehensive compliance policies and procedures that ensure the organization’s research activities adhere to all applicable laws and regulations.
• 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.

Minimum Education and Experience Requirements

• Required Education and Experience: Bachelor’s degree in relevant fields such as biology, public health, or regulatory affairs.
• Minimum 3-5 years of experience in regulatory affairs role.
• Preferred Education and Experience: Experience in academic research is highly preferred.

Knowledge, Skills and Abilities

• Familiarity with regulatory agencies and bodies.
• Strong organizational, leadership, and cross-cultural communication skills.