Position Summary

The Stony Brook Medicine (SBM) Director of Clinical Research Compliance and Privacy (DCRCP) will work with hospital leadership, faculty, and related operations teams to ensure current and ongoing management of and education regarding compliance programs that align operational practices with applicable policies and regulations. In this role, the DCRCP will collaborate with Stony Brook University Hospitals, The Renaissance School of Medicine and Stony Brook University leadership to ensure hospital research activities adhere to ethical and legal standards, policies and regulations. The DCRCP will also be required to lead work groups, present to leadership and oversee applicable education and training. The DCRCP will serve on the Executive Governance Compliance Committee and the Compliance and Audit Committee of the Governing Body.

Duties of a Director of Clinical Research Compliance and Privacy may include the following but are not limited to:

• The Director of Clinical Research Compliance and Privacy (DCRCP) is responsible for collaborating with the Office of Research Compliance, Office of the Vice President of Research, Vice Dean for Research, executive leadership department heads, programs directors and other research and academic leaders and teams to assure the development, implementation and ongoing improvement and assessment of the effectiveness of the seven elements of an effective compliance program for the research and academics mission areas.

• This role involves creating and implementing processes to assess, identify, manage and mitigate research compliance, billing and privacy risks; identify process gaps or control weakness; reduce the potential adverse effects of non-compliance; and develop/assure that effective corrective actions are implemented, as appropriate.

• The DCRCP serves as a resource, providing guidance to SBM leadership and staff on requirements and regulatory topics pertaining to research and academic compliance.

• The DCRCP develops, initiates, maintains, and revises the annual compliance and privacy work plan, as applicable for hospital research administration and operations and its related activities to prevent, detect, identify and mitigate illegal, unethical or improper conduct.

• The DCRCP acts as the primary point of contact for review of agreements that involve any transfers of protected data related to a research activity including the review Institutional Review Board submissions as needed and lead the Data Use Agreement Review Committee. The DCRCP further reviews certain non-disclosure agreements, complex sponsored research contracts, handle negotiation and processing of certain research agreements.

• The DCRCP conducts internal investigations of suspected privacy or research related billing compliance violations and recommend corrective actions and further, directs identified compliance issues to the appropriate existing channels for evaluation and resolution; and consults with the Office of Research Compliance and applicable departments to improve the compliance of processes; coordinates and prepares reports and assessments as appropriate .

• The DCRCP is expected to utilize clinical skills to inform role and design and perform detail testing to assess controls in place to address compliance and privacy risks related to clinical research.

• The DCRCP is expected to manage and develop, as needed, research related privacy and compliance policies and procedures consistent with applicable federal and state laws.

• The person is this role will develop and deliver applicable privacy and compliance training programs for research and clinical staff, including on topics such as billing and privacy compliance requirements and procedures, research misconduct, protection of human subjects, conflict of interest, effort reporting and responsible conduct of research.

• The person in this role will work closely with General Counsel's Office, Information Security, the Office of the Chief Research Information Officer, Office of Research Compliance, Stony Brook Medicine Privacy personnel, Office of Sponsored Programs, and Office of Vice President of Research.

• The DCRCP leads and supervises personnel as assigned; directs communications to teams; builds consensus and drives achievement of SBM research goals, objectives, and initiatives.

• The DCRCP assists the SBM Chief Compliance Officer as required.

• Performs other duties as assigned.

Qualifications

Required Qualifications:

• Master's degree in Health Policy, Business, Health Care Administration, Accounting/Finance, Law, Nursing, Health Sciences or a related field.

• Four (4) years' experience in human subject/clinical research or research compliance, including at least 1-2 years of experience clinical trial monitoring/auditing, research compliance, or regulatory oversight/project management of human subject research protocols.

• Ability to work collaboratively with clinical, financial, and other departments. Ability to manage multiple initiatives at the same time. In depth knowledge and understanding of fulfilling the elements of an effective compliance program. Strong analytical, communication, and presentation skills are required.

• Strong interpersonal and verbal communication skills

• Proficiency in written communication skills

Preferred Qualifications:

• Experience in a higher education environment

• Certification in Healthcare Research Compliance

Special Notes: Resume/CV should be included with the online application.

Posting Overview: This position will remain posted until filled or for a maximum of 90 days. An initial review of all applicants will occur two weeks from the posting date. Candidates are advised on the application that for full consideration, applications must be received before the initial review date (which is within two weeks of the posting date).

If within the initial review no candidate was selected to fill the position posted, additional applications will be considered for the posted position; however, the posting will close once a finalist is identified, and at minimal, two weeks after the initial posting date. Please note, that if no candidate were identified and hired within 90 days from initial posting, the posting would close for review, and possibly reposted at a later date.

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• Stony Brook Medicine is a smoke free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises.

• All Hospital positions may be subject to changes in pass days and shifts as necessary.

• This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair.

• This function/position may be designated as "essential." This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook University Hospital and related facilities.

Prior to start date, the selected candidate must meet the following requirements:

• Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services*

• Complete electronic reference check with a minimum of three (3) professional references.

• Successfully complete a 4 panel drug screen*

• Meet Regulatory Requirements for pre-employment screenings.

• Provide a copy of any required New York State license(s)/certificate(s).

Failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer.

*The hiring department will be responsible for any fee incurred for examination.

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Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.

If you need a disability-related accommodation, please call the University Office of Equity and Access at (631)632-6280.

In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here.

Stony Brook University Hospital, consistent with our shared core values and our intent to achieve excellence, remains dedicated to supporting healthier and more resilient communities, both locally and globally.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position is - $150000- $193000 / year.

The above salary range represents SBUH's good faith and reasonable estimate of the range of possible compensation at the time of posting. The specific salary offer will be based on the candidate's validated years of comparable experience. Any efforts to inflate or misrepresent experience are grounds for disqualification from the application process or termination of employment if hired.

Your total compensation goes beyond the number in your paycheck. SBUH provides generous leave, health plans, and state pension that add to your bottom line.

Visit our WHY WORK HERE page to learn about the total rewards we offer.