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HEALTH SCIENCE SPECIALIST

Employee will be assigned to the VA Medical Center, Salisbury, NC, and will be involved with a research program with responsibility for the coordination of research, administrative processes, and training with regard to research compliance.
Duties include, but may not be limited to the following:
Serves as the subject matter expert to the medical center's research leadership team and all VA researchers to assure the protection of human subjects involved in research with regard to safety and misconduct; to assure compliance with all biosafety and biosecurity requirements; and to assure compliance with all information security requirements; and consults with research coordinators and investigators to provide suggestions for improvements and modifications to submissions and/or practices.
Provides professional service to the Chair, Institutional Review Board (IRB), and research investigators involving the application of established principles, theories and concepts for exempted/expedited submission, amendments, continuing progress reports, and adverse events.
Identifies, develops and disseminates audit tools and mechanisms to assure compliance with Veterans Affairs, Association for the Accreditation of Human Research Protection Programs, Inc.
(AAHRPP), Office of Human Research Protections (OHRP), Food and Drug Administration (FDA), and other Federal and state regulations applicable to research; and conducts regular research protocol audits to determine compliance with all applicable policies and to ensure that informed consent has been properly obtained and documented for each subject.
Develops procedures and training modules for research employees, IRB, and Research & Development (R&D) members as required; monitors projects/grants compliance issues as they pertain to Conflict of Interest (COI); and consults with Regional Counsel on interpretation of regulations; and reports investigative findings to the appropriate committee.
Participates actively in implementing regulations and policies regarding research misconduct; develops and implements education program to ensure that investigators and staff are knowledgeable as to what constitutes research misconduct; and coordinates and conducts any investigation of alleged or suspected research misconduct.
Performs administrative reviews of all protocol submissions (e.
g.
, initial review, continuing review, modifications, etc.
) and responses to the IRB to assess accuracy and completeness of submissions; assesses new submissions to the IRB and forwards to appropriate board or IRB Chair for review or determination; attends IRB meetings, contributes to discussion, and facilitates the efficient functioning of the meetings; provides consultation to investigators and research coordinators on submission requirements to assist in the preparation of protocols; and reviews, edits, and performs quality review of IRB and R&D meeting minutes.
Develops education and training materials; trains investigators, research coordinators, research managers and others, as appropriate, regarding compliance with applicable research guidelines and regulations; and works with the VA IRB office in assuring that staff involved with human subject research are current on all required training.
Serves as a local resource for regulations, policies, memoranda, alerts, and other VA and federal requirements related to research compliance; and serves as a non-voting member on the IRB, Biosafety Committee, and Research and Development (R&D) Committee.
Prepares consolidated reports for management functions and higher echelon review, within and outside of the facility; and reviews recruitment process for participants by evaluating information on study objectives and constraints.
WORK SCHEDULE:
Monday -Friday, 8:
00am - 4:
30pm.


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