Health System Specialist

Research Committee Manager

The Research Committee Manager position is vital within the ORD and the facilities where research programs are conducted. Research Program Managers provide the link between Veterans and highly innovative projects. Duties and responsibilities include but are not limited to: R&D, IRB, IACUC, SRS, CIRB, IBC, and/or HRPP Program Administration.

• Oversees and manages these programs and their activities, including preparation of committee and reviewer materials with appropriate documentation, ensuring projects are reviewed by appropriate personnel, and ensuring all outstanding issues related to project management are resolved in a timely manner.
• Serves in an advisory capacity to the R&D Leadership, research investigators, research committee members, and research committee Chairs and others on issues relative to carrying out the institution's research activities involving the use of humans, animals, and safety procedures for investigative purposes.
• Serves as the accreditation Facility Liaison.
• Oversees the protocol review process of multiple programs and committees, ensuring projects are reviewed by appropriate personnel, including the Information System and Security Officer (ISSO) and Privacy Officer (PO), and issues related to project management are resolved.
• Develops and maintains a pre-review program that will coincide with the IRB, IACUC, SRS, IBC, CIRB, and/or R&D Committee review of all research involving human subjects, animal subjects, basic laboratory science and the human research protection program.
• Develops and manages required annual and semi-annual reviews of the assigned programs.
• Stays informed on guidelines relating to security and safety in the conduct of research and advises Research and Safety leadership, as needed.
• Educates the investigative community of local and external policies and procedures with regards to research involving animal and human subjects.
• Develops reporting procedures, sampling techniques, and measurements at various points in the research committee process and research programs to identify problem areas or inherent weaknesses in work processes, procedures, information systems and content.

Quality and Compliance

• Responsible for maintaining the federal-wide assurance with the Office of Human Research Protection and ensuring IRBs are appropriately constituted and registered.
• Responsible for maintaining the IBC registration with the National Institutes of Health Office of Science Policy and ensuring IBC is appropriately constituted and registered.
• Responsible for maintaining the program's accreditation process for the Association for the Assessment and Accreditation for Laboratory Animal Care International (AAALAC).
• Analyzes and evaluates each research project to ensure compliance with Federal and State regulations, including but not limited to VA, FDA, OHRP (Office of Human Research Protection), ORO, and other applicable regulatory and procedural requirements.
• Develops programs, policies, and procedures within the Research.
• Monitors quality assurance program implementation and indicators designed to prevent erroneous transactions and ineffective work practices and to verify adherence to quality assurance plans and requirements.
• Responsible for alerting investigators of deficiencies found within their submissions and educating them as to the steps required to correct the deficiencies.

Administrative Oversight

• Assumes responsibility in preparing for all external reviews.
• Research and/or analyzes problems, administrative issues, or program requirements as they relate to animal, human subject or safety research and the research review process.
• Initiates or reviews correspondence for all research.
• Oversees and refines customized, networked computerized databases to allow for timely tracking of research projects.
• Serves as the electronic records system administrator for the Research Office.

Work Schedule: Monday- Friday, 8am- 4:30pm

Position Description/PD#: Health System Specialist/ PD99586S