Conduct regulatory and clinical trials audits /reviews in accordance with appropriate standards, metrics, established research compliance plan(s) and prescribed institutional policies.
Prepare research compliance reports providing supporting evidence and recommendations regarding identified research compliance deficiencies or gaps.
Ensure findings and recommendations are adequately documented and audit work is performed according to appropriate auditing standards and policies.
Develop and reviews audit reports to support audit conclusions and provides summary of consulting engagements with regard to achieving understandability of audit issues and recommendations by all levels of management and the board.
Assist in investigations of alleged breaches of policy, misconduct, or other acts of research non-compliance to determine the cause, extent of risk and mechanisms for prevention.
Handle multiple concurrent requests from stakeholders requiring multiple and/or simultaneous deadlines as well as managing audits between peak periods.
Attends and participates in audit meetings.

Minimum Education: Bachelor’s degree; 3 additional years of experience plus the minimum experience requirement may substitute for minimum education.
Minimum Experience: At least five (5) years of experience in research compliance, preferably in a large academic medical center, or related experience in a similar field.
Skills/Abilities: Excellent attention to detail, strong written and verbal communication skills, and analytical and critical decision-making skills required.
Strong background in research compliance and operations.
Demonstrated experience with Good Clinical Practices and Human Subjects Research.
Experience in effectively developing and implementing comprehensive research audit programs.
Experience in healthcare research setting understanding institutional risk and applying appropriate judgement to use a risk-based approach in planning and executing duties.

Senior Compliance Analyst, Research Compliance

Key skills