Job Description:
Summary:
The Institutional Review Board Assistant will be responsible for co-managing the daily administrative activities of the Ballad Health Institutional Review Board (IRB) office. The Assistant shall provide consultation and instruction to individuals within the community. This individual will process all submissions to the IRB. This includes new applications, continuing renewals, amendments, SAEs, and other adverse event reports. The Assistant shall review claims of exemptions and expedited reviews as assigned, as well as to ensure all submissions meet the federal and state guidelines, as well as Ballad Health policies. The Assistant will manage protocol review information. The Assistant will designate the type of IRB board review required for each submission. This individual will assign scientifically appropriate submissions to the appropriate IRB board meeting agendas for review and create and maintain board meeting agendas. The Assistant shall maintain meeting minutes, IRB rosters, hard copies, electronic files, and all other required regulatory documents in compliance with federal regulations, institutional policies, and IRB SOPs. Additionally, the Assistant will initiate trials once the Principal Investigator has all IRB approval letters and stamped documentation through written correspondence to investigators of all IRB actions and decisions. The Assistant will manage and process all applications through IRBNet. This individual will answer questions related to submissions, FDA compliance, and general research education submitted by all investigators and research staff. The Assistant shall ensure research staff training and credentials are complete and accurate with each study submission. The Assistant will act as local administrator for IRBNet: maintain the local system and be a resource for local issues and maintain current IRB study files within a 10-year timeframe.
The Assistant will ensure that all Federal regulations are being followed and maintained. The Assistant will be knowledgeable of Code of Federal Regulations, Good Clinical Practice Guidelines, Common Rule, and basic research method. The Assistant shall be responsible for any additional duties as assigned.
Requirements:
Associates Degree preferred. Applicant must have organizational skills, ability to make deadlines,superior communication skills and be service oriented.
Work Requirements:
Shift: Day
On Call: No
Weekends: No
Travel Required: No Travel
Shift Details: 8a-5p
City/State: Kingsport, TN
Location: