Manages, plans, organizes, supports, and evaluates daily administrative operations for one or more defined compliance programs such as, but not limited to Health Insurance Portability and Accountability Act (HIPAA), Regulatory Affairs, Conflicts of Interests (COI) or other compliance program(s). Plans and implements research and audits and monitoring, evaluates and drafts findings and advises with organization leadership to provide education on regulations and mitigate compliance risk. Manages Compliance procedures and processes.
Manages the development of a research compliance and regulatory affairs program; produces a written plan of activities, addressing research compliance areas, with implementation plans, with the goal of achieving program goals and missions.
Ensures implementation and evaluation of research policies and procedures; reviews policies and procedures for consistency with applicable regulations and professional standards; collaborates with research administration leadership and others in making suggestions for change as needed.
Participates in assessment of research compliance risk areas and assists with documentation and regulatory risk assessments; develops, implements, and oversees audit and compliance monitoring program relating to research.
Determines audit or monitoring objectives, scope, and procedure, audits or monitors ongoing research studies to ensure practices are consistent with applicable regulations, policies, departmental standards, and regulatory approvals.
Drafts reports detailing audit findings and communicates with research stakeholders.
Promotes overall compliance with research through participation in education and training activities for professional staff; conducts research, interprets and communicates federal and state laws and guidelines pertaining to research.
Provides general compliance education and support to audit and facility staff involved in research; focused training based on results of compliance audits, monitoring and self-assessments.
Collaborates with internal audit, and faculty practice and corporate compliance to minimize overlap in compliance activities.
Operates under general guidance and work assignments are varied and require interpretation and independent decisions on course of action.
Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.