Health System Specialist (Research Compliance Officer)

Research Compliance Officer The Research Compliance Officer (RCO) evaluates compliance with Federal and VA requirements for the conduct of research, which may include requirements in one or more of the following areas: Protection of human research subjects, laboratory animal welfare, and research safety and security. Incumbent may also be assigned responsibilities related to facility programs for research information security, research privacy, conflict of interest in research, training of research personnel. Research program accreditation, research misconduct, and/or other research compliance activities consistent with VHA requirements. As a public agency, VHA has an obligation to preserve public trust in the integrity and quality of research carried out by its investigators, involving subjects in VA research, and in its facilities. Appropriate mechanisms must be in place to evaluate the functioning of the Human Research Protection Program (HRPP) and the safeguards in place to protect human research subjects in VA research. There must also be appropriately trained staff available at each VA facility conducting human subjects' research to audit each research project involving human subjects. The RCO leads the facility's research compliance program by providing expertise, strategic direction, and oversight. The role includes collaborating with senior health system and research leaders, developing compliance strategies, policies, and standards, evaluating program effectiveness, analyzing performance trends, and preparing compliance status reports. Duties may include, but are not limited to the following: Audits, Inspections, and Management Controls - 50%Develops and evaluates research compliance control systems, procedures, and audit processes. Audits human-subject and animal-subject research records for compliance with applicable regulations, standards, and accreditation requirements. Updates standard operating procedures and provides guidance on research compliance. Supports compliance across human and animal studies, laboratory and radiation safety, conflict of interest, information security, and privacy programs. Maintains complete and timely audit records, administrative and quantitative reports, and trend analyses. Ensures records are accessible to authorized officials and federal investigators and retained for potential ORO, FDA, ORD, USDA, and AAALAC inspections. Documents audits, inspections, management controls, serious or continuing noncompliance, unanticipated problems, systemic deficiencies, and other reportable events. Prepares and submits routine, for-cause, consolidated, and management reports to research review committees, facility leadership, national program offices, ORO, and applicable federal agencies. Performs quality assurance and quality management activities to prevent noncompliance, identify unfavorable trends, and correct contributing factors. Identifies systemic deficiencies that may compromise research protections or information security and ensures prompt reporting and follow-up. Develops and Maintains Working Relationships - 10%Maintains effective working relationships with the Information Security Officer, Privacy Officer, IRB, IACUC, research safety officials, radiation safety officials, and other relevant stakeholders. Provides routine compliance reports to the Health System Director and other facility leaders in accordance with VHA and facility requirements. Standards, Regulations, and Policy Development - 10%Disseminates regulatory and policy updates to research administrators, oversight committees, investigators, research personnel, and facility leadership. Serves as the local resource for regulations, policies, memoranda, alerts, and federal requirements related to research compliance. Maintains timely and open communication regarding research compliance issues. Training and Consultation - 10%Advises investigators, research coordinators, research committees, medical center leadership, and researchers on compliance practices and VA and federal regulatory requirements. Consults on the development and revision of Research Service and other facility standard operating procedures. Develops education and training materials related to research compliance auditing and regulations. Performs other related duties as assigned.