Clinical Protocol Developer

Culmen International is seeking a Clinical Protocol Developer to work on site in Portsmouth, VA at the Naval Medical Center Portsmouth.

• Assist physicians/scientists in developing, writing, and producing human and animal research protocols in support of the military medicine research programs
• Assist with the preparation of investigator-initiated trials to include coordination of the protocol submission, submission of amendments and regulatory compliance reports, and the development of presentations and/or publications
• 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 with ensuring PI-initiated protocols contain quality research design, and meet DOD standards for ethics and compliance
• Assist the PI with addressing Scientific Review Committee (SRC), Institutional Review Board (IRB), and other committee queries
• Attend and assist with the planning of committee meetings for disease-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
• Work with the data management team, clinical operations team, and other research collaborators in transitioning projects from the development team to the operations team that incorporates the clinical details needed to treat patients and the research elements to answer study questions
• Assist the clinical research coordinators 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)
• Participate in the collection of data, supporting both human and animal protocols.
• Provide education and training to researchers and staff on protocol development