Required Qualifications: (As evidenced by an Attached Resume)
Advanced degree in a science, public health, law or other related field. Minimum of 7 years of experience in positions providing oversight of the ethical conduct of research and compliance with federal regulations. Command of human research protections and IRB policies and procedures. Strong leadership skills as evidenced by at least 3 years of supervisory experience of professional and support staff. Capable of developing and implementing regulatory strategies, policies and procedures and managing complex compliance programs. Excellent oral and written communication skills.
PhD, MD or JD. At least two years of experience in an Assistant/Associate Vice President, Director or Assistant/Associate Director role in a research compliance office. Experience in conducting or overseeing clinical research. Direct experience with human research accreditation processes such as AAHRPP. Experience with related enterprise systems such as Huron Click, IRBNet, and/or similar systems.
Brief Description of Duties:
The AVP will provide a high-level of administrative services and leadership for the day-to-day operations of the Office of Research Compliance, in the Office of the Vice President for Research, to ensure safe, ethical and responsible conduct of research. This position reports to the Vice President for Research and supervises 8+ professional staff, along with student staff. This assignment requires in-depth knowledge of Federal and State regulations, thus ensuring a compliant research compliance program. This position includes operation of numerous oversight committees, promulgation of policies and guidance, personal interaction with researchers and collaboration with other administrative units as well as outside entities including SUNY and RF Central, federal agencies and research sponsors.
Incumbent must demonstrate strong leadership ability, strong interpersonal skills, and verbal and written communication skills to effectively interact with and lead a wide range of constituencies. Candidate must be a self-starter, skilled in critical analysis with outstanding problem solving skills, must possess high ethical standards and the ability to exercise judgment and discretion in interpreting and applying regulations and procedures. Candidate must demonstrate the ability to work collaboratively in a team environment. Candidate must have a strong working knowledge with Microsoft Office Products, Adobe, and related enterprise systems such as Huron Click, IRBNet, clinicaltrials.gov, or similar systems.
Specific responsibilities include:
Develop and implement University policies and procedures to ensure research compliance with Federal and State regulations pertaining to responsible conduct of research, human subject research, animal research, recombinant or synthetic nucleic acid molecules, stem cells, radiopharmaceuticals, investigator financial conflict of interest, research misconduct and export controls.
Serve as Institutional Official for the human research protection program, Deputy Institutional Official for the animal welfare program and Research Integrity Officer for research misconduct allegations and cases.
Coordinate with other University offices as appropriate, such as General Counsel, Sponsored Programs, Grants Management, Technology Transfer and Industry Relations, Office of Clinical Trials, Office of Cancer Clinical Trials, Scientific Affairs and Environmental Health and Safety, to ensure and improve University conduct of research, to investigate possible research malfeasance and to resolve compliance issues as they arise.
Ensure necessary and appropriate communication between the University and Federal and State entities to maintain University research operations in compliance with government regulations, to report mandated reportable compliance events, and to confirm correct interpretation/implementation of numerous regulations.
Maintain a liaison with SUNY Counsel and Audit Management on regulatory matters or issues of interpretation, risk management, legal/compliance issues and research misconduct proceedings.
Serve as Research Foundation contact for HIPAA compliance in human subject research activities. Function as coordinator for compliance with SBU’s Misconduct in Science policy when involved. Communicate with RF counsel regarding continuing legal/compliance issues.
Oversee, manage the compliance of, provide guidance to and serve as a consultant to research review committees such as the Institutional Review Boards (IRBs), including independent IRBs, the National Cancer Institute’s adult and pediatric IRBs, and IRBs of other institutions, in compliance with NIH policy and upcoming federal regulations, as well as Institutional Animal Care & Use Committee, Institutional Biosafety Committee, the Stem Cell Research Oversight Committee, Investigator Conflict of Interest Committee and Radioactive Drug Research Committee.
Negotiate with sponsors (NIH, pharmaceutical companies, etc.) to streamline consent document language and to clarify difficult areas of requests.
Conduct reviews of IRB & IACUC protocols and evaluate protocols involving compliance activities to ensure they are in line with relevant regulations and policies. Closely monitor compliance and AQ/QI Initiatives for active human research.
Develop training, educational materials, web-based tools, and outreach programs for the University community and work directly as necessary with faculty, staff and students to ensure compliant and responsible conduct of research.
Monitor developments and changes in statutes, court rulings, rules and regulations that impact research compliance requirements. Promptly respond to, and disseminate to the research community, periodic changes in Federal regulations and other guidelines.
Other duties as assigned appropriate to grade and departmental mission.
The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.
Stony Brook University, home to many highly ranked graduate research programs, is located 60 miles from New York City on Long Island's scenic North Shore. Our 1,100-acre campus is home to 24,000 undergraduate, graduate, and doctoral students and more than 13,500 faculty and staff. SBU is a comprehensive research-intensive university and a member of the prestigious Association of American Universities (AAU), which includes 34 public universities among its 62 members. SBU consists of 12 schools and colleges and a teaching hospital that provides state-of-the-art healthcare in the Long Island region. SBU also manages and performs joint research with Brookhaven National Laboratory, the only Department of Energy Laboratory in the Northeast, and shares doctoral programs with Cold Spring Harbor Laboratory, a world-renowned molecular biology institute. Home to the Emerson String Quartet, the Jackson Pollock House in East Hampton, New York, the Humanities Institute, and the Southampton Arts Program, and with endeavors that extend to the Turkana Basin Institute in Kenya and the Ranomafana National Park in Madagascar, SBU sustains an international reputation that cuts across the arts, humanities, social sciences, and natural sciences.
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