PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
Serves under the normal supervision of the Chief, Human Research Protections Office (HRPO) who is also the BAMC Human Protections Administrator (HPA), who assigns overall area of responsibility, sets broad program objectives and provides consultative input only. Incumbent is responsible for both fully understanding and supporting the Region and MTF Human Research Protection Program (HRPP), a broad and coordinated program of regulatory compliance that deals with critical scientific and ethical issues. Within this framework, the incumbent will possess and maintain a broad understanding of the applicable Federal (including Department of Defense), state and local regulations/policies which serve to shape the program. The incumbent will recommend and substantiate any changes to the HRPP, subject to the approval of the HPA. The incumbent will assist in evaluating scientific reviews of research planned for conduct under the HRPP. This encompasses broad consideration of scientific merit, research design, statistical analyses and results dissemination. Technical interpretations, recommendations and conclusions in this regard are considered authoritative and are not normally given a further review. The incumbent will communicate with both investigators and key leaders across the organization to ensure execution of the duties.
1. RESEARCH REGULATORY REVIEW: Serves as a senior IRB staff member and authority in the area of human research protections. Provides guidance and assistance to junior staff in the area of human research protections. Responsible for conducting the regulatory review and approval process of submitted new protocols, amendments, deviation reports and continuing review submissions, as assigned by the HPA. Assigned work will include research in the area of social and behavioral sciences and research with complicated design and/or regulatory concerns. As a senior staff member, formulates, recommends and implements solutions to complex problems and challenges related to human subjects research. Works to maintain regulatory compliance while reducing unnecessary burdens. Will also review submitted proposals for other determinations such as exempt research, research not involving human subjects or performance improvement. Will serve as an alternate IRB member for the purpose of approving expedited human research and/or to serve on the convened Board. Will be responsible for generating all regulatory forms required to make determinations and document all findings for subsequent approval by the IRB or Institutional Official. May assist the HPA in negotiating institutional agreements for IRB review. 40%
2. RESEARCH SCIENTIFIC REVIEW: As a subject matter expert on design, conduct, analysis and presentation of research and will independently comment on researcher proposals. Will work closely with both investigators and regulatory officials to explain scientific concerns and to achieve consensus regarding methods for accomplishing the research which are consistent with sound scientific principles. As appropriate, will also integrate the complex process of scientific and ethical review at RHC/BAMC and with numerous collaborating Institutional Review Boards (IRBs). 30%
3. POLICY DEVELOPMENT: Responsible for assisting the HPA in the development new policies to keep the RHC and BAMC Human Research Protection Program and IRB current with the latest concepts in medical bioethics. This includes participating in the annual review of existing standard operating procedures and accomplishing required revisions. To facilitate this review, the incumbent will maintain current knowledge of the latest Federal (including Department of Defense), State and local regulations/guidelines. The incumbent will develop any required forms or other educational tools, as directed by the HPA, to ensure policies are successfully implemented. 10%
4. EDUCATION: Will foster regulatory compliance and sound scientific design to ensure human subject protection through education and training of personnel. In this capacity, the incumbent may be called upon to provide individual or group education, of either an informal or formal nature. Will support the educational efforts of the RHC/BAMC HRPO Post Approval Compliance Monitoring Office. 10%
5. COMPUTER/METRIC SUPPORT: Will assist investigators and RHC/BAMC HRPO staff with the use of computer software required for the submission, review and approval of research protocols. Through this assistance, will participate in the generation of metrics to evaluate the activities of the IRB for purposes of command reporting and for development of performance improvement efforts. 10%
Certified Institutional Review Board Professional (CCIP)
2 years or more experience in interpreting and applying regulations to approve clinical trials
Additional Salary Information: Federal Benefits apply
Internal Number: 3355714
About US Army- Brooke Army Medical Center
Brooke Army Medical Center (BAMC) at Fort Sam Houston, Texas, is proud to provide safe, quality care to our military service members, their families, veterans and civilian emergency patients as the most robust and productive healthcare organization within the Military Health System (MHS). Both inpatient and outpatient services are provided by approximately 8,500 staff members, including active duty military personnel from each of our uniformed services, Public Health personnel, federal civilians, contract employees, and volunteers.
A central part of our medical center is the San Antonio Military Medical Center (SAMMC), which provides safe, quality, evidence-based care for up to 425 military and civilian inpatients.
As the sole verified Level I Trauma Center within the Department of Defense (DoD), BAMC simultaneously provides emergency services during 80,000 Emergency Department visits annually and serves as the premier medical readiness training platform for both the Army and the Air Force.
BAMC providers also care for more than 4,000 patients each day during visits to its six separate outpatient clinics including: Westover Medical Home, CPT Jennifer M. Moreno Primary Care... Clinic, McWethy Troop Medical Clinic, Taylor Burk Clinic at Camp Bullis, the Schertz Medical Home, and the Corpus Christi Occupational Health Clinic. Prominent on the hospital campus, and surrounded by four Fisher Houses, the four-story Center for the Intrepid (CFI) stands as a pre-eminent extremity injury rehabilitation center.
Forty of the hospital’s beds are designated for the US Army Institute for Surgical Research (USAISR) Burn Center. The verified Burn Center serves alongside the Level I Trauma Center to provide emergency services for residents from 22 separate counties in South Texas.
As a proud partner within the San Antonio Military Health System (SAMHS), BAMC facilities provide comprehensive care for more than 250,000 military beneficiaries living throughout the area. BAMC and its Air Force partner, the 59th Medical Wing, including the Wilford Hall Ambulatory Surgical Center, forged the SAMHS to optimize military medical resources in and around Joint Base San Antonio.
The BAMC Team is proud to provide compassionate, patient-centered care to our military families and our civilian patients each day.