Program Manager, Research Compliance
- GENERAL SUMMARY
- 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. This role will also be responsible for oversight of external audit readiness. Reports to departmental leadership.
- ESSENTIAL DUTIES AND RESPONSIBILITIES
- Program Administration:
- 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, extract information, and help 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 to identify and resolve any instances of non-compliance and mitigate risks.
- Leads the internal auditing team to ensure external audit readiness.
- 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.
- Administrative:
- 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.
- Program Administration:
- LICENSES AND/OR CERTIFICATIONS
- Required Licenses and/or Certifications
- None
- Required Licenses and/or Certifications
- 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.
- Required Knowledge, Skills and Abilities
- Familiarity with regulatory agencies and bodies.
- Strong organizational, leadership, and cross-cultural communication skills.
- Required Education and Experience
- WORKING CONDITIONS
- Normal office environment with little exposure to excessive noise, dust, temperature and the like.
- PHYSICAL REQUIREMENTS
- Click here to view physical requirements.
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