JOB DESCRIPTION:
Under the general direction of the Director of NKI, the Compliance Officer (CO) provides leadership and oversight for NKI's comprehensive Research Compliance Program. The CO ensures that research activities across the institution comply with applicable federal, state, and local regulations, sponsor requirements, and institutional policies.
The CO oversees compliance across human subjects' protections, animal welfare, conflicts of interest, research integrity, bio-safety, privacy and data security, investigational drugs and devices, research billing, export controls, and grant/contract compliance. The CO promotes a culture of ethical, safe, and responsible research.
JOB DUTIES:
• Mentor compliance leads across functional areas (HRPP, IACUC, biosafety, privacy/security, research administration, etc.) to support effective operations and continuous improvement.
• Audit, Monitoring & Investigations
• Conduct and prepare an annual risk assessment and compliance workplan
• Conduct or coordinate monitoring, audits, investigations, and assessments of potential noncompliance.
• Serve as institutional liaison during internal and external audits and regulatory inspections; oversee development and implementation of corrective action plans.
• Develop, monitor, and report compliance metrics to leadership
• Policy Development & Program Enhancement
• Develop, revise, and implement research compliance policies, SOPs, and guidance documents.
• Maintain awareness of regulatory changes and ensure timely institutional updates.
• Develop and implement training programs.
Once established, the CO will proactively continue to develop new policies, programs, and procedures as needed to ensure that research compliance keeps pace with a dynamic regulatory environment and that the administration and constituents are kept aware of regulatory changes to mitigate unnecessary exposure to risk. Inherent in this work will be monitoring changes in federal regulations and state laws and, in turn, advising and educating institutional leadership, investigators, and staff on their impact on research compliance, human subject protection and animal research. The CO will ensure that research leaders and managers maintain continuously updated knowledge of current federal, state, and local regulations regarding research, including compliance with all required training and/or certifications.
JOB QUALIFICATIONS:
Minimum Qualifications:
• An M.A./M.S. Degree or equivalent related experience.
• A minimum of three years of experience in research compliance oversight in an academic medical center.
• Comprehensive knowledge of ethical issues, state laws, policies, and regulations pertaining to the protection of human research subjects.
• Demonstrated experience in guiding organizational compliance strategy, including implementing new initiatives and protocols.
• Prior experience and proven success in establishing a culture of compliance across research units.
Additionally, all candidates must be eligible to participate in Federal health care programs (e.g., Medicaid). Individuals excluded from participation in these programs will not be considered.
Preferred Qualifications:
At least one of the following: Certified IRB Professional (CIP), Certified Research Associate (CRA), Certified Clinical Research Associate (CCRA), or equivalent training or experience (such as an attorney or auditor with the necessary experience).
Background Investigation/Justice Center Review Requirements:
Prospective appointees will be: 1) Checked against the Staff Exclusion List (SEL) maintained by the Justice Center for the Protection of People with Special Needs. Prospective employees whose names appear on the SEL as having been found responsible for serious or repeated acts of abuse or neglect will be barred from appointment. 2) Screened against the Statewide Central Register of Child Abuse and Maltreatment (SCR). Prospective employees whose names are indicated on the SCR may be barred from appointment.
Applications will only be accepted through website at: - Click on Employment Opportunities. Applications will be accepted only during the posting dates as listed at the top of the job announcement.
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