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Corporate Compliance & Research Compliance Program Manager

Company: Hartford HealthCare
Location: Hartford
Posted on: April 8, 2021

Job Description:

Job DescriptionJob Schedule: Full Time Standard Hours: 40 Job Shift: Shift 1 Shift Details: 40 Hours per week Work where every moment matters. Every day, almost 30,000 Hartford HealthCare colleagues come to work with one thing in common: Pride in what we do, knowing every moment matters here. We invite you to become part of Connecticut's most comprehensive healthcare network. The story of Hartford HealthCare is the story of transformation - from a handful of disconnected organizations a decade ago to a unified system with a shared, value-based culture of accountability and innovation. The healthcare landscape has become highly competitive, with new players and disruptive technology and we are working to expand and create our system's organizational, leadership, cultural, and talent capabilities to ensure Hartford HealthCare will always be the first choice of the people we serve. The Program Manager of Clinical Research Compliance, develops strong relationships with the Director of Clinical Research and the Director of Human Research Subject Protection to provide oversight and expertise for the design, implementation, and ongoing monitoring of an effective compliance program for human subject research. Develops and maintains understanding of all HHC human subject and animal research programs and is responsible for the investigation and resolution of research compliance issues, maintenance of research compliance policies and procedures, coordinating external audits and reviews, and performing ongoing auditing and monitoring for compliance with pertinent regulations. Responsibilities include but, are not limited to the following: * Serves as HHC's subject matter expert for regulations and guidelines related to clinical research including, but not limited to: the Uniform Guidance; National Institutes of Health Grants Policy Statement; regulations governing research conflicts of interest; human subject research protections; animal subject protections; foreign influence; environmental health & safety; export controls related to international research engagements; and, clinical research billing. Develops strong partnership with HHC Privacy Officer on clinical research-related HIPAA Privacy matters. Leads and/or participates in meetings and committees designed to oversee compliance in all aspects of clinical research. * Manages all aspects of clinical research compliance including, but not limited to: interpreting and applying regulatory laws and guidance governing research, including financial and non-financial regulations; responding to adverse events; investigating protocol deviations and allegations of clinical research misconduct; participating in, and responding to, external audits and other routine and non-routine auditing and monitoring activity performed by study sponsors, federal agencies or other designated oversight agencies. * Maintains all investigation notes and files in a contemporaneous, organized manner within the OCI incident reporting database. Strives to close all investigations and respond to all routine inquiries within OCI department standards and industry benchmarks. Escalates urgent issues to OCI leadership when necessary. * Exhibits critical thinking skills to identify and respond to potential compliance program violations. Recommends solutions and corrective actions to remediate any identified compliance program violations and monitors the successful implementation and sustainability of associated corrective action plans. Recommends specific sanctions and disciplinary measures when necessary and appropriate. * Implements policies and procedures that govern the research compliance program and ensure the program is structured to prevent, detect, and equitably resolve research compliance issues. * Serves as the key corporate compliance liaison to one or more specific Regions and/or Networks of HHC. In the capacity of the OCI liaison, develops and maintains strong working relationships with leadership and prepares quarterly reports to the Regional ELT to keep them apprised of compliance-related activities and investigations impacting the Region/Network. * Conducts risk assessments on a continuous basis to evaluate and mitigate both corporate compliance and research compliance-related risk. Links risk assessment activity to the development and prioritization of annual OCI Work Plan. * Provides communication and training to the HHC community on research compliance-related matters. Addresses new and emerging compliance laws and requirements in collaboration with HHC management, including the development of education materials and policies and procedures as necessary. Oversees response and communicates new regulatory changes to affected departments/individuals by assembling work groups and developing/providing education and training. * Maintain current knowledge of applicable federal and state laws and other regulations and accreditation standards, and monitor compliance and audit standards and changes in regu

Keywords: Hartford HealthCare, Hartford , Corporate Compliance & Research Compliance Program Manager, Executive , Hartford, Connecticut

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