Clinical Protocol Developer

Job Description

GDIT is seeking 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. Responsibilities:

• 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. 

Qualifications

• Master’s Degree
• 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

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.