![Nemours](https://media.trabajo.org/img/noimg.jpg)
Director of Research Compliance
1 month ago
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.
-
Director of Research Compliance
1 month ago
Wilmington, Delaware, United States Nemours Full timeNemours 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...
-
Executive Director of Compliance
2 months ago
Wilmington, North Carolina, United States Johns Hopkins Medicine Full timeSummaryThe Executive Director of Corporate Compliance and Regulatory Affairs ("Exec. Director") at Johns Hopkins Health Plans (JHHP) reports to the Johns Hopkins Health System (JHHS) Chief Compliance Officer (and reports via a matrix relationship to the President of JHHP). The Exec. Director is responsible for the development, implementation, communication,...
-
Senior Director, Clinical Research
1 month ago
Wilmington, United States Proclinical Full timeSenior Director of Clinical Research - Contract - Wilmington, DE Proclinical is seeking a dedicated and innovative individual for the role of Senior Director, Clinical Research. Primary Responsibilities:This role involves collaborating with physicians within Clinical Development to provide clinical research support for various programs. The successful...
-
Senior Director, Clinical Research
1 month ago
Wilmington, United States Proclinical Staffing Full timeSenior Director of Clinical Research - Contract - Wilmington, DE Proclinical is seeking a dedicated and innovative individual for the role of Senior Director, Clinical Research. Primary Responsibilities:This role involves collaborating with physicians within Clinical Development to provide clinical research support for various programs. The successful...
-
Senior Director, Clinical Research
1 month ago
Wilmington, United States Proclinical Staffing Full timeSenior Director of Clinical Research - Contract - Wilmington, DE Proclinical is seeking a dedicated and innovative individual for the role of Senior Director, Clinical Research. Primary Responsibilities:This role involves collaborating with physicians within Clinical Development to provide clinical research support for various programs. The successful...
-
Trauma Research Improvement Coordinator
1 week ago
Wilmington, Delaware, United States Nemours Children's Health Full timePosition Overview:Nemours Children's Health is seeking a dedicated Registered Nurse for the role of Trauma Research Performance Improvement Coordinator. This position is integral to the operations of a Level I trauma center, focusing on research and performance enhancement activities. Key Responsibilities:The Trauma Performance Improvement (PI) / Research...
-
Trauma Research Performance Improvement Coordinator
2 months ago
Wilmington, United States Nemours Children's Health Full timeJob DescriptionNemours is seeking an Registered Nurse for the Trauma Research Performance Improvement Coordinator position! Research and performance improvement activities are essential components of a Level I trauma center. The trauma performance improvement (PI) / research coordinator works collaboratively with the Trauma Program Manager, Trauma Medical...
-
Director, Global SOX Program Compliance
2 weeks ago
Wilmington, United States Analog Devices Full timeAnalog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...
-
Senior Research Scientist
1 month ago
Wilmington, Delaware, United States Nemours Full timeWith recent significant expansion in our research portfolios, particularly related to research on pediatric health equity, The Center for Healthcare Delivery Science (CHDS) at Nemours Children's Health is pleased to announce the availability of a new faculty position for a mid or senior career faculty member. This position is based in Delaware and is...
-
Wilmington, Delaware, United States CSC Full timeManaging Director, Investor Services and Compliance (North America)Hybrid-Wilmington, DE or West Orange, NJMonday to Friday 9:00 a.m. to 6:00 p.m. ESTCandidates for this position must be eligible to work in the United States without sponsorship. Time on-site or time zone may be necessary based on business need.Position Summary: CSC Fund Solutions, North...
-
Wilmington, United States CSC Full timeManaging Director, Investor Services and Compliance (North America) Hybrid-Wilmington, DE or West Orange, NJ Monday to Friday 9:00 a.m. to 6:00 p.m. EST Candidates for this position must be eligible to work in the United States without sponsorship. Time on-site or time zone may be necessary based on business need. Position Summary: CSC Fund Solutions,...
-
Medical Director
4 days ago
Wilmington, United States Reflections of Hope Full time*Medical Director Job Description**Title: Medical Director*Department: AdministrationReports To: CEOFLSA Status: Non-Exempt, hourly up to 40 hours per weekWork Hours: variable, based on clinic needs*Summary:*The Medical Director at ROH is responsible for medical operations of the treatment program. The Medical Director assumes responsibility for...
-
Medical Director
7 days ago
Wilmington, United States Reflections of Hope Full time*Medical Director Job Description**Title: Medical Director*Department: AdministrationReports To: CEOFLSA Status: Non-Exempt, hourly up to 40 hours per weekWork Hours: variable, based on clinic needs*Summary:*The Medical Director at ROH is responsible for medical operations of the treatment program. The Medical Director assumes responsibility for...
-
Environmental Compliance Specialist
3 months ago
Wilmington, United States GPM Investments LLC Full timeJob DescriptionJob DescriptionOverviewThe Environmental Compliance Specialist is responsible for, among other duties; providing support the regional environmental manager, interacts with regulatory agencies, monitors leak detection and compliance testing of the underground storage tanks systems, monitors and controls spending, and coordinates emergency...
-
Compliance-Executive Director
3 weeks ago
Wilmington, United States JPMorgan Chase Full timeBring your expertise to JPMorgan Chase. As part of Risk Management and Compliance, you are at the center of keeping JPMorgan Chase strong and resilient. You help the firm grow its business in a responsible way by anticipating new and emerging risks, and using your expert judgement to solve real- world challenges that impact our company, customers and...
-
Clinical Trials Manager-Research
3 months ago
Wilmington, United States Nemours Full timeThe Clinical Trials Manager provides strategic planning, growth, and development for Clinical Research conducted in the Delaware Valley. The incumbent supervises and coordinates the responsibilities of clinical research assistants, clinical research coordinators, clinical research nurses and staff conducting studies and oversees the management of all...
-
Aquaculture Research Faculty
1 week ago
Wilmington, North Carolina, United States University of North Carolina Wilmington Full timePosition OverviewThis role is pivotal in leading the Finfish Aquaculture Research Program at the University of North Carolina Wilmington. The successful candidate will take charge of various research initiatives and will be expected to:Conduct Comprehensive Research: Engage in innovative studies within the field of aquaculture.Principal Investigator...
-
Clinical Trials Manager-Research
5 days ago
Wilmington, Delaware, United States Nemours Full timeJob Summary:The Clinical Trials Manager-Research is responsible for the strategic planning, growth, and development of clinical research conducted in the Delaware Valley. This role oversees the management of all clinical research projects conducted at Nemours Children's Hospital-Delaware and works closely with the Unit's Medical Director to manage the...
-
Academic Researcher in Microeconomics
12 hours ago
Wilmington, North Carolina, United States University of North Carolina Wilmington Full timeThe University of North Carolina Wilmington's Department of Economics and Finance is seeking a highly qualified individual to fill a tenure-track position in applied microeconomics. The successful candidate will be expected to contribute to the department's research and teaching mission, with a focus on applied microeconomics and a preference for health or...
-
Compliance Officer
4 days ago
Wilmington, Delaware, United States Kalexius Full timeWe are seeking a Corporate Governance specialist to join our Legal Entity Management Team at Kalexius, a leading alternative legal services provider. Our innovative solutions cater to the legal departments of large companies and law firms.Key Responsibilities:Conduct thorough research to ensure compliance with corporate obligations across multiple...