Exciting opportunity with the Research Compliance Division at Spartanburg Regional
The Research Compliance Systems Manager participates in the development and support of solutions, technological and otherwise, to improve compliance and business efficiency and productivity for research and all of its internal and external functions, including the Institutional Review Boards (IRB). Acts as a liaison between internal (NCCCP, CCOP, Regulatory Affairs, CTMS and IRB) and between these internal group and external workgroups including state programs as directed (HSSC). Monitors compliance with federal regulations clinical research through practice, professional societies and other documented resources as appropriate. Monitors changes in the research compliance and clinical research compliance environment including OIG and other federal investigations or publications. Communicates regulatory changes to internal and external functions including necessary systems change recommendations. Interacts with compliance, research and IRB staffs on a daily basis. Provides administrative activities and support of the IRB and Clinical Trials technology products with minimal assistance from internal IS resources, including project planning, system design, build and testing, end user training, pre-live planning and system live and support transition. Leads or actively participates in all workgroups to assure technology and database applications comply with federal regulations governing Institutional Review Boards, Clinical Research and Spartanburg Regional standards and policies. Provides support as needed for Human Subject Research Protection compliance.Responsible for:-Represents the clinical needs of SRHS in the development and integration of the eIRB and CTMS web-applications in cooperation with HSSC.-Manages a SRHS team for clinical-expertise contribution to (1) the CTMS web-application development and implementation, and (2) the eIRB web-application implementation to assure that SRHS needs are addressed by the applications.-Team-builds and coordinates workgroups within SRHS as needed to facilitate effective compliance and integration of design and usage of research-related systems with regulations and policies.-Educates and trains research and compliance staffs regarding the use of the eIRB and CTMS web-applications including ongoing analysis of application utilization and productivity. Provides ongoing education as indicated.-Manages eIRB access for IRB, investigators and supportive roles.-Provides daily administrative support of the eIRB and CTMS web-applications through all stages and ongoing support post live status.-Addresses all ongoing needs identified through direct contact, system reports, external reports and federal regulations in the eIRB and CTMS web-applications.-Manages auditing of investigator-initiated research to ensure compliance with regulations and policy.-Provides leadership in select AAHRP domains of standard (Investigator and -Sponsor Research) and support for other areas of the accreditation process and continuance.JOB/EDUCATION REQUIREMENTS:-Current South Carolina RN License-Eight years experience in Clinical Research, Institutional Review Board or Research Compliance.-3 + years quality assurance/regulatory compliance experience-Extensive database and computer usage knowledge