Clinical Research Director Assistant

Clinical Research Director Assistant

Requirements

• Bachelor of Science Degree with 5+ years of experience in clinical research or a Master’s/PhD in scientific field with 2+ years
• Documented authorship of scientific publications
• Experience in developing and designing research protocols
• Experience with research compliance and auditing
• Recent knowledge (within 5 years) of research compliance guidance as outlined in the Office of Human Research Protection (OHRP) and Office of Laboratory Animal Welfare (OLAW) policies and regulations
• The Contractor Personnel shall have and maintain a current Basic Life Support (BLS) certification
• Intermediate+ experience with Microsoft Office applications including: Word, Excel, PowerPoint, and Outlook
• US Citizenship with the ability to pass a public trust investigation

Responsibilities

• Assists in institutional research for the 59th Medical Wing
• 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 Medical Center 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 institutions
• Acts as an appointed non-voting member of the IRB
• Determines 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 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 Medical Wing
• Ensures appropriate training is completed as required and that all personnel meet compliance regulations pertaining to research being conducted within the control of the WHMC IRB
• Assist 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
• Review protocol changes submitted to the IRB required changes and assists in approval and concurrence actions from the Air Force Surgeon General’s Office

Preferred Qualifications

• Experience and broad knowledge of medical, nursing or allied health care fields used to interpret research functions
• Working general knowledge of various medical specialties to thoroughly understand the primary ideas/intent outlined in protocol documents and is able to identify and recommend modifications to correct issues or inconsistencies
• Experience or knowledge of research methodology and experimental design to ensure that protocols are properly developed to meet all compliance guidelines
• Experience and ability to clearly articulate objectives, recommendations and decision, to prepare and present materials and other literature designed for the research process
• Effective interpersonal relation skills to diplomatically deal with novice and seasoned researchers in a number of medical specialties
• Ability to assist in the planning, organizing and administering a variety of programs and activities related to research protocols