Clinical Protocol Developer

Responsibilities

• Support the Department Head of CID and the PI of each protocol in accordance with written policies and procedures as set forth in Title 21 of the Code of Federal Regulations, NMCP and Bureau of Medicine & Surgery (BUMED) instructions
• Aid physicians/scientists in developing, writing, and producing human and animal research protocols in support of the military medicine research programs
• Prepare investigator-initiated trials, including coordination of protocol submission, amendment submissions, and regulatory compliance reports
• Develop and produce 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
• Ensure PI-initiated protocols meet DOD standards for ethics and compliance
• Assist with planning and attending committee meetings for disease-specific working groups
• Administer the study development tracking system and update protocol details and development events in eIRB system
• Collaborate with the data management team, clinical operations team, and other research collaborators to transition projects from development to operations
• Work with clinical research coordinators to develop specimen submission processes
• Collaborate with research and statistical data coordinators, database developers, and database administrators in study database development and data monitoring planning
• Collect and report information on protocol inconsistencies and clarifications
• Facilitate the registration of studies on clinicaltrials.gov, including QA processes
• Support the collection of data for both human and animal protocols
• Provide education and training to researchers and staff on protocol development

Qualifications

Commensurate with experience

Skills

N/A

Benefits

N/A

Pay

N/A

Schedule

N/A