We are GDIT. As one of the largest IT and mission services providers to the government, we own our opportunities to better enable healthcare organizations to identify theirs.You can make GDIT your place. You make it your own by turning obstacles into action. By owning your opportunity at GDIT, you’ll play an important role in providing the technologies and services that millions of healthcare professionals depend on, every day. Our work depends on a Clinical Protocol Developer joining our team to support the Naval Medical Center (NMCP) activities in Portsmouth VA.At GDIT, we put our people first. As a Clinical Protocol Developer to support the development and execution of IRB- or IACUC-approved investigator-initiated research protocols using human subjects and animal models. This position will primarily be responsible for developing research protocols for the Military Health System in the area of combat casualty care/battlefield health and emergency medicine.In this role, a typical day will include:
Assist physicians/scientists in developing, writing and producing human and animal research protocols in support of combat casualty care research.
Assist the PIs with the preparation of new investigator-initiated trials, coordination of the submission, submission of amendments and regulatory compliance reports, and the development of the final product (presentation and/or publication).
Effectively communicate with physicians (study chairs and scientific committee chairs) and other research collaborators, such as biostatisticians and basic scientists, who are part of the various working groups.
Assist with preparing informed consent statements and other study related research documents.
Conduct literature reviews and draft scientific and technical documents.
Contribute to the preparation and modification of internal study budgets.
Assist the with ensuring PI-initiated protocols contain quality research design, and meet DoD standards for ethics and compliance.
Assist with the amendment of existing investigator-initiated protocols.
Assist the PI with addressing Scientific Review Committee (SRC), Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC) and other committee queries.
Attend and assist with the planning of committee meetings for specific working groups to facilitate research development.
Assist with administering the study development tracking system and updating protocol details and development events in eIRB system.
Assist the clinical research coordinator in the development of specimen submission.
Assist the research and statistical data coordinators, database developers and database administrators in study database development and data monitoring planning.
Assist with collecting information on reported problems regarding consistency and/or clarity in open protocols.
Assist with initial and follow-on updates of study registration on clinicaltrials.gov, including facilitation of Quality Assurance (QA) Review comments with coordination of the PIs.
Participate in the collection of data, supporting both human and animal protocols.
Provide education and training to researchers and staff on protocol development within and outside department.
WHAT YOU’LL NEED:Qualifications:
5+ years relevant experience supporting the development of research protocols for IRB/IACUC approval
Experience in the collection of data, supporting both human and animal protocols
Must be a US citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date.
Experience working within combat casualty care, wound healing, hemorrhage control, vascular trauma, polytrauma areas a plus
WHAT GDIT CAN OFFER YOU:
401K with company match
Customizable health benefits packages
Internal mobility team dedicated to helping you own your career
Challenging work that makes a real impact on the world around you
Full-flex work week
GDIT CAREERSOpportunity OwnedNot sure this job’s the one for you? Check out our other openings at gdit.com/careers.
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
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.