Director Of Research Compliance

Min 5 yrs required

Full-time

No

# Director of Research Compliance (Hybrid)

Nemours is seeking a Director of Research Compliance to join our Nemours Children’s Health team in DE or FL. 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.

## Job Requirements

* Master’s Degree required (and areas of study should include health policy, research administration, business administration or legal/regulatory). 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.

## Job Description

The Director of Research Compliance implements, directs, and leads the research compliance program related to all research including clinical, translational, and other research. This position is responsible for:

* Coordinating and supporting existing research compliance activities across the organization regarding federal and state laws and regulations, accreditation and certification requirements, and other applicable standards.
* Developing, implementing, maintaining, and overseeing policies and procedures regarding compliance with federal and state laws and regulations associated with external funding of research activities.
* Developing, implementing, and directing the export compliance program for the organization 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”).
* Developing, implementing, maintaining, and overseeing training and education program for research compliance issues, including, for example, new hire orientation, annual mandatory research compliance training and department-specific training.
* Developing annual work plan to address identified risks, including conducting risk assessment, audit and monitoring activities.
* Conducting inquiries and investigations relating to allegations of research misconduct and works with the Committee for Research Integrity (“CRI”).
* Serving as a resource on the laws, regulations, and internal policies related to research including . Department of Health and Human Services, . Department of Agriculture, and Food and Drug Administration (“FDA”) regulations.
* Providing 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.
* Staying current with relevant federal and state research compliance laws and regulations and modifying 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.

## About Nemours

Nemours is one of the nation's premier pediatric health care systems, dedicated to doing whatever it takes to prevent and treat even the most disabling childhood conditions. Our mission extends beyond our nationally recognized clinical treatment to an entire integrated spectrum of research, advocacy, education, and prevention.

At Nemours, we are committed to providing culturally relevant care, reducing health disparities, and helping build a diverse and inclusive environment. We are looking for individuals who are passionate about, and committed to, leading efforts to achieve this goal.

Candidates of diverse backgrounds, race and ethnicity, religion, age, gender, sexual orientation, and those committed to working with diverse populations and conversant in multicultural values are strongly encouraged to apply.

## Job Info

* Job Identification: 10780
* Job Category: Leadership
* Posting Date: 01/05/2024, 02:53 AM
* Degree Level: Master's Degree
* Job Schedule: Full time
* Locations: 1600 Rockland Road, Wilmington, DE, 19803, US
* Salary: Commensurate with experience

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