PRINCIPAL DUTIES AND RESPONSIBILITIES:
Assists in directing and overseeing institutional research for the 59th MDW.
Assists in operations of the IRB and preparing protocols to go through the board process.
Works with investigators in preparing and reviewing protocols ensuring protocols meet all applicable Air Force, DoD, and Federal requirements.
Manages data collection and analysis and oversees the formulation of research reports (i.e., reports to higher headquarters, accrediting agencies, research partners, etc.)
Assists presiding member of the Wilford Hall Ambulatory Surgical Center (WHASC) IRB to develop processes to review and coordinate all research protocols in accordance with the Common Rule, Belmont Report, and other federal, DoD and AF regulations.
Assists in developing and writing operating instructions for all processes associated with performing research within the institution.
Assists in determining category of IRB approval required for studies submitted.
Assists in preparing IRB agenda working with the IRB Presiding Member and IRB protocol staff and publishes agenda.
Assists in tracking all ongoing approval and concurrence actions from Higher Headquarters and coordinates actions with principle investigators, IRB members, and Division personnel.
Assists in controlling protocol documentation, establishing suspense’s and ensuring documentation is complete and prepared for scheduled IRB meetings.
Assists in completion and review of IRB minutes, reviewing for completeness and thoroughness prior to submission for signature and coordination with higher headquarters review. Assists in ensuring that minutes contain all pertinent information relevant to risk determination and regulatory compliance to expedite review by outside compliance agencies.
Assists in tracking training and compliance issues of all individual investigators involved in research in the 59th MDW, ensuring appropriate training is completed as required and that all personnel meet compliance regulations pertaining to research being conducted within the control of the WHASC IRB.
Assists IRB Chair and Presiding Official in conducting meetings ensuring required members are available, votes are cast, and conflict of interest issues are resolved in accordance with commonly accepted rules of order. Assists in mediating disagreements between board members using the Common Rule, Air Force and DoD instructions and current interpretation of all directives established by research compliance oversight bodies.
Reviews protocol changes submitted to fulfill IRB required revisions and assists in approval and concurrence actions from the Air Force Surgeon General’s office.
Will serve as an appointed non ‐ voting member of the Institutional Review Board, observing and providing guidance to the members regarding Human Subject Protection.
Provide all job-related progress reports/technical reports as requested.
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
Performs light duties and other related duties as required and assigned.
As a minimum this position requires the equivalent of a Ph.D or Masters Graduate Degree in scientific discipline and a minimum of five years of experience in research oversight and compliance review relevant to the aforementioned activities.
Must be able to work independently following a brief period of specific technical training.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment: laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.
ClinicalRM is a Contract Research Organization supporting government and commercial clinical research for biologics, drugs, and devices.