Corporate Compliance & Research Compliance Program Manager
Company: Hartford HealthCare
Location: Hartford
Posted on: February 20, 2021
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Job Description:
Description Job Schedule: Full TimeStandard Hours: 40Job Shift:
Shift 1Shift 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 regulations
to ensure organizational adaptation and compliance. Qualifications
Education:--- Bachelor's Degree required.--- MBA, MHA, JD with
major coursework in business administration, health care
administration, or law preferred.Experience:--- A minimum of six
(6) years of health care compliance experience with a specific
focus on clinical research, preferably in a large healthcare system
setting or in an academic medical center. Licensure, Certification,
Registration--- Certified in Healthcare Compliance (CHC) or
Certified Compliance & Ethics Professional (CCEP) & Certified in
Healthcare Research Compliance (CHRC)We take great care of
careers.With locations around the state, Hartford HealthCare offers
exciting opportunities for career development and growth. Here, you
are part of an organization on the cutting edge - helping to bring
new technologies, breakthrough treatments and community education
to countless men, women and children. We know that a thriving
organization starts with thriving employees-- we provide a
competitive benefits program designed to ensure work/life balance.
Every moment matters. And this is your moment.
Keywords: Hartford HealthCare, Hartford , Corporate Compliance & Research Compliance Program Manager, Executive , Hartford, Connecticut
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