DescriptionJOB DESCRIPTION:
- The Senior Research Compliance Specialist ensures institutional compliance with federal, state, sponsor, and university research regulations and policies.
- This role conducts compliance reviews and risk assessments, supports investigations and issue resolution, provides training and guidance, and contributes to the development and continuous improvement of research compliance programs.
- The position partners closely with faculty, research staff, and central administration to promote a strong culture of compliance and responsible research conduct.
- Senior Research Compliance Specialists may be assigned one or more regulatory specializations based on institutional needs.
- These specializations define the primary regulatory focus and required subject-matter expertise for the role, such as research integrity, controlled substances, research cybersecurity, or research security.
- Conducts risk-based reviews, audits, and monitoring of research activities to assess compliance with applicable regulations, sponsor requirements, and institutional policies.
- Supports and manages investigations and issue resolution related to research compliance, including documentation, analysis, reporting, and corrective and preventive actions.
- Develops, implements, and maintains research compliance policies, procedures, guidance, and operational tools.
- Provides training, education, and consultative support to faculty, research staff, and administrators on research compliance requirements.
- Prepares reports, metrics, and documentation to support compliance monitoring, program evaluation, and leadership reporting.
- Maintains accurate and secure program records and ensures the integrity and confidentiality of sensitive information.
- Collaborates with departments, committees, central offices, and external partners (e.g., IT, vendors) to support research compliance programs and enterprise systems.
- Contributes to continuous improvement of research compliance programs and promotes a positive culture of compliance and responsible research conduct.
- Performs related responsibilities as required.
Regulatory Specialization:
The Senior Research Compliance Specialist may be assigned one or more regulatory specializations based on institutional needs. Regulatory specializations define the primary regulatory domain and subject-matter expertise required for the role and do not change the underlying job classification.
Research Integrity
• Supports intake, assessment, and review of research misconduct allegations.
• Assists with research integrity investigations, including evidence review, interviews, documentation, and reporting.
• Provides guidance on research integrity policies, procedures, and responsible conduct of research requirements.
• Supports FDA inspections, IND/IDE application reviews, stem cell reviews and other research regulatory assistance as needed
MINIMUM QUALIFICATIONS:
- Bachelor's degree and five years of experience in research administration, research compliance, internal audit, legal, audit, or a related field.
- Experience in a university or research environment involving heavily regulated industries preferred.
- Juris Doctorate or master's degree and Certified Compliance and Ethics Professional (CCEP), Certified in Healthcare Research Compliance (CHRC), or similar certification preferred.
NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department. This role requires residency in the state of GA. Emory reserves the right to change remote work status with notice to employee.
