Req ID: RQ185470

Type of Requisition: Regular

Clearance Level Must Be Able to Obtain: None

Public Trust/Other Required: NACLC (T3)

Job Family: Research

Skills:

Clinical Research,Clinical Research Administration,Human Subjects Research,Research Protocols

Experience:

5 + years of related experience

US Citizenship Required:

Yes

Job Description:

GDIT's Military Health team is hiring a Senior Clinical Research Administration Manager to support research within the Air Force- 59th Medical Wing located, on-site, at Lackland Air Force Base in San Antonio, TX.

The 59th Medical Wing Science and Technology (ST) office advises and conducts clinical and translational research on matters pertaining to the medical aspects of the Air Expeditionary Force and the health of Air Force (AF) personnel and beneficiaries. In order to support the required research, ST offices conduct translational research in the areas of emergency medical care, combat casualty care, force health protection, restorative medicine, clinical and rehabilitative medicine and specialty centers.

Learn More Here --> https://www.59mdw.af.mil/

How You Will Make An Impact:

• Supports the CIRS Office of Protocol Support and Human Protection Administrator (HPA) in oversight of institutional research conducted at the 59th Medical Wing. Manages and provides complex regulatory support of human subjects research, exempt determinations and protocols, animal research, non-human research, etc., with primary emphasis on human subjects research.

• Works with the HPA, protocol support staff, and investigators in preparing protocols for submission to the San Antonio Institutional Review Board (IRB).

• Works with the Animal Care and Use Program (ACUP) Clinical Research Administrator and Attending Veterinarian, protocol support staff, and investigators in preparing protocols for submission to the Institutional Animal Care and Use Committee (IACUC) process. Guides and trains investigators in preparing and reviewing protocols, ensuring protocols meet all applicable Defense Health Agency (DHS), DoD, Federal and accreditation requirements.

• Manages metrics data collection and analysis and oversees the formulation of productivity and other research-related reports. Guides protocol support staff in data collection and report completion. Devises and submits recurring reports to higher headquarters, accrediting agencies, research partners, etc.

• Advises Human Protections Administrator (HPA) and Branch Chief, Office of Research Protocol Support, on development of processes to review and coordinate all research protocols in accordance with the Revised Common Rule, Belmont Report, Animal Welfare Act and amendments, Public Health Service Policy, other federal, DoD and DHA regulations, and accreditation standards.

• As required, advises the Animal Care and Use Program Research Administrator/IACUC Chair on development of processes to review and coordinate all research protocols in accordance with the Animal Welfare Act and amendments, Public Health Service Policy, other federal, DoD and DHA regulations, and accreditation standards.

• Develops and writes operating instructions for all processes associated with regulatory support of research protocols within the institution. Advises on and reviews institutional policies to enable effective implementation of regulatory and DoD policy requirements. Works closely with the Institution’s regulatory leads to ensure that all research meets all relevant Federal and DoD regulatory requirements.

• Supports Exempt Determination Officials and IRB Designated Reviewers in determining category of IRB approval required for studies submitted.

• Conducts protocol submission administrative reviews, in coordination with the HPA and/or the ACUP Clinical Research Administrator, to ensure all required documents are reviewed and finalized for IRB and/or IACUC review.

• Manages and tracks all ongoing approval and concurrence actions from Higher Headquarters and coordinates actions with principal investigators and research staff.

• Establishes procedures for controlling protocol documentation, establishing suspense’s, and ensuring documentation is complete and prepared for submission to the appropriate regulatory committee.

• Tracks training and compliance issues of all individual investigators involved in research, ensuring appropriate training is completed as required, and that all personnel meet compliance regulations pertaining to research being conducted.

• As required, works with IACUC Chair in conducting meetings for the IACUC.

• Reviews protocol changes submitted to fulfill IRB required stipulations and assists in approval and concurrence actions from the DHA Office of Research Protection.

• Conducts training on the DHA’s electronic institutional review board System (eIRB) for investigators and research staff. Advises on eIRB system performance and required changes.

• Compiles protocol records and workload data for periodic DHA and Air Force staff assistance visits, and AAHRPP and AAALAC International accreditation site visits. Participates in site visits as a subject matter expert.

• In coordination with the HPA, manages and maintains DoD and Federal Wide Assurance documentation and registration.

• Participates in institutional, Joint Base San Antonio, and DHA-level working group meetings. Plans, executes, and serves as a speaker at the annual Research Fundamentals Workshop.

• US Citizenship required with the ability to pass a favorable public trust security investigation.

What You'll Need (required):

• Bachelor of Science Degree with 5+ years of experience in medical research, human subjects research protocol administration OR Master’s in a scientific field can substitute for 3 years of required experience.

• Experience in human subjects research regulatory compliance.

• 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 regulatory 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 several medical specialties, as well as professionals and staffs at the unit and headquarters levels.

• Ability to assist in planning, organizing, and administering a variety of programs and activities related to research protocols.

• Recent knowledge (within 5 years) of human subjects research compliance guidance as outlined in the NIH’s Office of Human Research Protections (OHRP) policies and regulations. Knowledge of DoD or DHA guidance and policy, 3 years of human subjects research experience, or Certified IRP Professional credentials can substitute for the OHRP recency requirement.

• US citizenship required with the ability to pass a favorable public trust investigation.

WHAT WOULD BE EVEN BETTER (PREFERRED):

• PhD.

• Experience in animal research regulatory compliance.

• Recent knowledge (within 5 years) of animal research compliance guidance.

GDIT IS YOUR PLACE:

• 401K with company match

• Comprehensive health and wellness packages

• Internal mobility team dedicated to helping you own your career

• Professional growth opportunities including paid education and certifications

• Cutting-edge technology you can learn from

• Rest and recharge with paid vacation and holidays

#GDITFedHealthJobs   

#GDITHealth

#MilitaryHealthGDITJobs 

#GDITpriority

The likely salary range for this position is $60,549 - $70,150. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.

Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.

We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 30 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.

We connect people with the most impactful client missions, creating an unparalleled work experience that allows them to see their impact every day. We create opportunities for our people to lead and learn simultaneously. From securing our nation’s most sensitive systems, to enabling digital transformation and cloud adoption, our people are the ones who make change real.

GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.