Required Qualifications: (As evidenced by an attached resume)
Bachelor's degree or higher in a science discipline or Bioethics plus a minimum of 7 years of experience in positions providing oversight on the ethical conduct of research and compliance with federal regulations or a Master's degree or higher plus a minimum of 5 years of experience in positions providing oversight on the ethical conduct of research and compliance with federal regulations. Proven understanding of scientific and clinical terms. Prior supervisory experience with a demonstrated ability to supervise professional and support staff. Ability to analyze, interpret, develop and manage complex policies and procedures and respond effectively to the most sensitive inquiries to the research community. Excellent oral and written communication skills.
PhD in a science discipline or MD. Experience as 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 Director will provide a high-level of administrative services and leadership for the day-to-day operations of the Office of Research Compliance to ensure safe, ethical and responsible conduct of research. This position reports to the Vice President for Research and supervises a total of eight professional staff, along with student staff. This assignment is multifaceted, and extremely complex. It requires in-depth knowledge of Federal and State regulations, thus ensuring a compliant research compliance program. This 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, Brookhaven National Laboratory, 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 possess strong time management, organizational and planning skills with the ability to prioritize multiple tasks. A strong focus on project management and attention to detail is essential. Candidate must demonstrate the ability to work collaboratively in a team environment. Candidate must have a strong working knowledge with Microsoft Office Products, Adobe, SharePoint, and related enterprise systems such as Huron Click, IRBNet, clinicaltrials.gov, or similar systems.
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.
Participate in broader University and School of Medicine/Medical Center Committees to discuss and create new University and School of Medicine policies and procedures.
Coordinate with other University offices as appropriate, such as the 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.
Act as an advisor to the Vice President for Research and Operations Manager on all issues concerning responsible and compliant conduct of research.
Provide advice to and counsel Audit Management on complex compliance risk management and control issues.
Maintain a liaison with SUNY Counsel on regulatory matters or issues of interpretation, 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.
Recruit members for all boards, including actively recruiting federally mandated community members.
Communicate with other universities in collaborative research endeavors to ensure facilitation of the activity.
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.
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, and promptly respond to periodic changes in Federal regulations and other guidelines.
Disseminate up-to-date news on regulations to appropriate parties in a timely fashion.
Directly supervise 2 Assistant Directors who manage 6 staff members to include assigning and directing work, appraising work performance, managing employee corrective action, addressing complaints and resolving problems.
Implement changes in office operations as needed to be responsive to faculty.
Drive teamwork within and between departments and organizations.
Ongoing monitoring of compliance and AQ/QI Initiatives for active human research.
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. This position requires occasional work on weekends or in evenings.
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 1,040-acre campus is home to 24,600 undergraduate, graduate, and doctoral students and more than 13,500 faculty and staff. The University is a member of the prestigious Association of American Universities and co-manager of nearby Brookhaven National Laboratory, a multidisciplinary research laboratory supporting world class scientific programs utilizing state-of-the-art facilities. Stony Brook Medicine is Suffolk County's only academic medical center and tertiary care provider. Many opportunities exist for collaborative research, and in some cases, joint appointments with BNL or with Medical School departments.
Equal Opportunity Employer, females, minorities, disabled and veterans.
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