IRB Administrator

7 days left

Camp Lejeune, NC
Aug 16, 2017
Sep 30, 2017
Full Time
  • Provide support to the IRB Chair, and Primary Investigator (PI) of each protocol in accordance with written federal, Department of Defense (DoD), Department of the Navy (DoN), Bureau of Medicine and Surgery (BUMED), and Command regulations, policies, and procedures. 
  • Provide the Government with monthly Metrics for DoD assessment of approved research protocols. Reports the data by maintaining a database of all research projects. Respond to unscheduled DoD queries on topics such as research related to military relevance, traumatic brain injury (TBI), post-traumatic stress disorder (PTSD), and combat readiness, etc. Has minimal supervision when satisfying both regular and unscheduled requests for data.
  • Review new research protocols for consistency, completeness, and compliance with all DoD DoN, BUMED, NMCCL, and other federal and applicable state regulations and guidelines prior to IRB review.
  • Assist Government personnel to determine the adequacy of protocol submissions prior to IRB review. Advise PIs on how to remain in compliance with the guidelines and regulations. When plans are not in compliance, use knowledge of the technical and administrative requirements of the protocol in order to recommend changes to the PI. 
  • Review all complete project submissions, determine review type, recommend assignment of reviewers, and recommend exempt status. The IRBA advises investigators on proposed ethical practices, patient safety, and patient rights; facilitates approval by the IRB; assesses risk and channels applications to one of three levels of review and IRB oversight (Exempt, Expedited or Full Board).
  • Identify ethical, legal, and other issues that might be controversial or counter to society's mandates and mediates corrective measures with the investigator for remediation.
  • Ensure budgets, consent forms, receipt of gifts, grants, or donations, and human use issues are addressed in each protocol as it relates to the administrative and procedural guidelines.
  • Receive protocols after they have been endorsed by the Research Quality Council (RQC)/ Scientific Research Council (SRC) and then assign the protocol to the IRB. The IRBA takes the initiative to address any administrative complications as they arise and, if unable to achieve adequate resolution, seeks the assistance of higher lines of authority.
  • Review Informed Consent Documents (ICDs) for protocol and amendment‐specific content and to ensure presence of federally mandated elements of informed consent. 
  • Communicate to PI items that require clarification, or documents required for submission, to complete a research application for IRB review.
  • Write correspondence to PIs to communicate the decisions of the IRB.
  • Evaluate reports of unanticipated problems, amendments and continuing review forms, and prepare recommendations to the committee.
  • Monitor the regulatory environment and recommend changes, as needed, to institutional officials.
  • Ensures all studies performed are in accordance with the approved protocol and applicable regulations.
  • Track DoN-HRPP reporting of newly-approved protocols and post approval action completions in the format of meeting agenda and minutes reports by the Protocol Facilitator. Work with the Protocol Facilitator to document that DoN-HRPP reporting is submitted consistently, accurately, and in a timely manner.
  • Coordinate a team approach to produce the IRB agenda for each meeting and ensure that materials are distributed in a timely matter within established guidelines.
  • Create and disseminate the schedule and agenda for IRB meetings. Coordinate initial review of protocols with investigators and notifies investigators regarding administrative and IRB requirements. Coordinate continuing review of protocols with investigators and direct notification of investigators regarding administrative and IRB requirements.
  • Assists with development and maintenance of the IRB forms. Ensure that forms adequately document current study activity and regulatory criteria, such as inclusion of vulnerable populations, identification of risk level, and approval of Waiver of Consent or Waiver of Authorization for the Use of PHI, so that expedited reviewers or the convened Board have sufficient information to take action upon submitted materials. 
  • Assist in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions. 
  • Assist with training and orientation tasks of new committee members.
  • Work collaboratively to facilitate ongoing development, implementation and maintenance of the human subject’s protection program.
  • Support the IRB Chairman and is accountable for IRB administrative matters. Independent judgment is exercised to determine appropriate action and priorities in the performance of duties.
  • A Bachelor’s Degree or higher in medicine, medical research, biological science, behavioral health, health science, physiology, or nursing is required.
  • Evidence of post-baccalaureate advanced education to include a Master’s Degree or certification as a Registered Nurse, preferred.
  • A minimum of four years’ experience providing direct administration or management of a human subjects research IRB conducting active research protocols; OR a minimum of two years’ experience providing direct administration or management of a human subjects research IRB conducting active research protocols (four years preferred) with certification as a National Association of IRB Leaders (NAIM) Certified IRB Manager (CIM) or Public Responsibility In Medicine and Research (PRIMR) Certified IRB Professional (CIP).
  • Will be adept in the use of managerial skills, communication skills and leadership skills to assist the PI in the administration of complex human research protocols. 
  • Knowledge of applicable Department of Defense (DoD), Department of the Navy (DoN), Health and Human Services (HHS), Food and Drug Administration (FDA) policies, guidelines and regulations, and federal and state laws pertaining to the use of human subjects in research - to include the use of investigative drugs/devices. Applicable relevant directives include, but not limited to: 45 CFR 46, DoDI 3216.02, SECNAVINST 3900.39, and BUMEDINST 6000.12. 
  • Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonisation (ICH) regulations and IND/IDE requirements. Knowledge of medical terminology and treatment concepts. 
  • A comprehensive, practical knowledge of a clinical research program that includes: protocol preparation, processing for approval, and continuing review; methods of communication with investigators, with command, and with higher headquarters and outside agencies; protocol tracking and data storage; and consent form regulations. 
  • Ppersonal and professional skills to interact professionally and effectively and conduct collaborations with investigators, sponsors, and multidisciplinary teams and to participate with higher authorities and colleagues in a variety of settings. Skill in delivering recommendations that may be disputed to a varied group of managerial and professional staff.
  • Skill in using desktop and networked computer software, to include intermediate or advanced level competencies with Microsoft Windows and the Microsoft Office suite (Outlook, Word, Excel). Ability to learn and master proprietary software such as EIRB, ProIRB, PROMIS and IRBNet protocol data management software, as these programs are critical to the day-to-day operations of the IRB and CID.

 As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.