Executive Director of Research Operations

The Office of the Senior Vice President for Research is seeking a full-time Executive Director of Research Operations. The Executive Director of Research Operations will be an experienced and innovative leader skilled at collaborating with all levels of faculty, staff, and students across Touro University, and within the university affiliates and external contacts. Reporting to the Senior Vice President for Research (SVPR), the Executive Director of Research Operations is responsible for regulatory oversight and compliance of university research and teaching programs with applicable federal state local and organizational rules, regulations, policies, and guidelines. These responsibilities include identifying and/or investigating research noncompliance or nonconformance with appropriate rules, regulations, and/or guidelines. The Executive Director of Research Operations will have oversight of the Clinical Trials Unit (CTU), Office of Research Administration (ORA), the Department of Comparative Medicine (DCM) and BioInc@NYMC (BioInc). The successful candidate should have experience in human clinical trial coordination. The position is located on the NYMC campus in Valhalla, NY.

Office of the SVP for Research:

• Collaborate with the SVPR to develop and implement research strategies and manage special projects, ensuring seamless coordination with core office staff and the compliance team.
• Support the preparation for leadership meetings, demonstrating professionalism in interactions with senior executives.
• Provide project management assistance for research initiatives associated with NYMC and Touro University, including but not limited to the specified subunits.

Clinical Trials Unit (CTU)

• The Executive Director of Research Operations will provide administrative oversight, leadership, and supervision for NYMC CTU and will work closely with the Administrator to develop the enterprise.
• Responsible for all aspects of clinical research projects across the Network, including but not limited to: initial review of new study applications, communications with principal investigators and study teams, contract negotiation, budget development, monitoring of an education/training of EDCs (such as REDCap).
• Collaborate with clinicians who are responsible for intake physicals, obtaining informed consent, and implementing/conducting clinical trials.
• Generate periodic status reports on active research studies for Senior VP and leadership.
• Develop and implement Scope of Practice and other compliance documents to continue the function of the CTU.
• Apply and maintain proper local, state, and federal license needed for the operation of the CTU (such as CLIA waivers, etc.).

Office Research Administration (ORA) & Institutional Review Board (IRB, NYMC and TU)

• Assists SVPR in review, update, and development of policies and procedures for ORA functions, with emphasis on intellectual property and contract administration.
• Oversees the ORA website and other outreach to the NYMC and Touro University System research community.
• Partners with institutional academic leadership to conceive, promote, and support initiatives aimed at encouraging faculty and students to pursue research and other sponsored program activities.
• Assist in oversight of the sponsored programs offices of New York and the Western Division (Touro University California; Touro University Nevada, Lovelace Biomedical Research Institute).
• Work closely with the Director, Human Subjects Administration, and Institutional Review Board committees.
• Collaborates effectively with partner hospitals and clinics engaged in clinical research.
• Assist in the review of submitted patents, licensing of patents, and maintenance of existing patent portfolio.

BioInc NYMC

• Work in tandem with the Coordinator to interface for candidate companies, client firms, service providers, and the NYMC/Touro community and responsible for managing the operations, planning, marketing, strategic direction, and development of BioInc and supporting the correlative aspects of the TruMada initiative.
• Work with BioInc tenants to optimize their development and commercial opportunities.
• Solicit new tenants and maintain a robust portfolio of innovative companies.

Department of Comparative Medicine (DCM)

• The Executive Director of Research Operations will work with Director of DCM for the implementation of the program of animal care and use.
• Serve on the Institutional animal care and use committee (IACUC).
• Work with DCM to maintain all federal and local registrations and licensures and maintain AAALAC-International accreditation and remain in good standing with regulatory agencies.

Financial Management

• Assist in preparation and management of department budget for OVPR, DCM, BioInc, CTU, Environmental Health and Safety, Biosafety Level -3 Laboratory, ORA, and Touro University Office of Sponsored Projects budgets.
• Prepare and implement financial plans, forecasts, and budgets.
• Negotiate contracts and agreements with vendors and other companies.

Education

• An appropriate academic degree, accompanied by work experience, demonstrating knowledge of management of research operations. Examples include: BS in Nursing, Master of Nursing, Doctor of Nursing Practice, MS in Clinical Research, MPH, DPH, MS, MHA, MBA, Master’s in Physician Assistant.

Licensures/ Certifications

• Collaborative Institutional Training Initiative certifications preferred (but can be trained at NYMC).

Prior Experience

• Experience in running and implementing successful research operations.

Knowledge/ Skills/ Abilities

• Ability to work effectively both as part of a team and independently is essential.
• Excellent oral and written English communication skills.
• Good organizational and analytical/ problem-solving skills with strong attention to detail.
• Ability to work productively with minimal supervision.
• Ability to attain, maintain, and apply a working knowledge of Good Clinical Practices and applicable SOPs.

Technical/ Computer Skills

• Ability to use a combination of validated Electronic Data Capture (EDC) systems and/ or other internal or commercial software tools.
• Proven experience using data management systems, tools, and processes to support multi-sit, multi-mode research studies.

• Strong technical skills, including excellent knowledge of various software programs and packages including MS Word, Excel.

Travel

• Travel to Touro University divisions and external contacts may be required