Director of Research Compliance
Company: Asct
Location: Wilmington
Posted on: October 8, 2024
Job Description:
Nemours is seeking a Director of Research Compliance (hybrid or
remote) to join our Nemours Children's Health team in DE or FL. The
Director of Research Compliance implements, directs, and leads the
Nemours research compliance program related to all research
including clinical, translational, and other research. The Director
will be responsible for the creation of the Office of Research
Compliance. This position provides leadership and guidance in all
aspects of the research compliance program, including
responsibility for investigation and resolution of research
compliance issues; conducting a research compliance risk
assessment; maintenance of research compliance policies and
procedures; providing regulatory guidance and advice on research
compliance matters; and conducting or coordinating focused training
and education on research compliance. Essential Functions
- Coordinates and supports existing research compliance
activities across Nemours regarding federal and state laws and
regulations, accreditation and certification requirements, and
other applicable standards.
- Achieves research compliance objectives by working with a
variety of Nemours departments and offices, including Research
Administration, Research Finance, Research Operations, Office of
Sponsored Programs ("OSP"), Institutional Review Board ("IRB"),
Institutional Animal Care and Use Committee ("IACUC"),
Institutional Biosafety Committee ("IBC"), Quality Assurance and
Education ("QA"), Billing Compliance, Privacy, and Financial
Conflicts of Interest ("FCOI").
- Works well and coordinates with counterparts at other
institutions and outside research sites.
- Develops, implements, maintains, and oversees policies and
procedures regarding compliance with federal and state laws and
regulations associated with external funding of research activities
including effort reporting, allowable cost principles, subrecipient
monitoring, and other requirements for recipients of federal and
nonfederal funding.
- Develops, implements, and directs the export compliance program
for Nemours to ensure compliance with export control laws and
regulations, including the International Traffic in Arms
Regulations ("ITAR"), the Export Administration Regulations
("EAR"), and the regulations administered by the Treasury
Department's Office of Foreign Assets Control ("OFAC").
- Develops, implements, maintains, and oversees training and
education program for research compliance issues, including, for
example, new hire orientation, annual mandatory research compliance
training, and department-specific training.
- Develops annual work plan to address identified risks,
including conducting risk assessment, audit, and monitoring
activities. Oversees external entities retained for reviews. May
review all documents and other information relevant to research
activities.
- Conducts inquiries and investigations relating to allegations
of research misconduct and works with the Committee for Research
Integrity ("CRI"). Receives, investigates, documents, and tracks
research compliance complaints from workforce members, patients
and/or family members, the Compliance Helpline, or other sources.
Develops and implements (or oversees implementation of) corrective
action plans (including ensuring consistent application of
disciplinary action standards) in response to such complaints and
investigations.
- Serves as a resource on the laws, regulations, and internal
policies related to research including U.S. Department of Health
and Human Services, U.S. Department of Agriculture, and Food and
Drug Administration ("FDA") regulations. This includes the use and
disclosure of protected health Information ("PHI") for research
purposes in coordination with the Chief Privacy Officer.
- Provides guidance on federal and state laws and regulations, as
well as commercial insurance policies, regarding the billing and
payment for services rendered to human subjects on clinical
trials.
- Stays current with relevant federal and state research
compliance laws and regulations and modifies the research
compliance program accordingly to remain compliant, as well as
consistent with industry best practices; cooperates with federal
and state entities in any research compliance program audits,
inquiries, or investigations. Requirements Bachelor's Degree
required. Master's Degree (and areas of study should include health
policy, research administration, business administration or
legal/regulatory) preferred. Post Graduate Juris Doctorate degree
preferred. Must have valid compliance certifications: Certified in
Healthcare Compliance (CHC) and Certified in Healthcare Research
Compliance (CHRC) Certified in Healthcare Privacy Compliance (CHPC)
preferred Minimum 5 years of experience in the research compliance
field required; 7+ years preferred.
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Keywords: Asct, Bel Air South , Director of Research Compliance, Executive , Wilmington, Maryland
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