Clinical Research Manager / Protocol Developer
General Dynamics Information Technology (GDIT) is hiring for full-timeClinical Protocol Developerto join the GDITteam at theNaval Medical Center Portsmouth (NMCP).
As the U. S. Navy's oldest, continuously-operating hospital since 1830, Naval Medical Center Portsmouth (NMCP) proudly serves past and present military members and their families. The nationally acclaimed, state-of-the-art medical center, including its nine branch clinics located throughout the Hampton Roads area, additionally offers premier research and teaching programs designed to prepare new doctors, nurses and hospital corpsmen for future roles in healing and wellness.
The Clinical Protocol Developer performs research, analysis, development and evaluation of systems, procedures and models in assigned functional area.
- Works with physicians/scientists to assist in developing, writing and producing human and animal research protocols that are within the scope of NMCP's Clinical Investigation Program.
- In consultation with the principal investigators (PI's) prepares new investigator-initiated trials, coordinate the submission, submit amendments and regulatory compliance reports, and ensure final product development (presentation and/or publication).
- Responsible for coordinating communication between 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.
- Assists with writing informed consent statements and other study related research documents.
- Conducts literature reviews and drafts scientific and technical documents under the direction of the PI.
- Contributes to the development and modifications of study budgets.
- Ensure that investigator-initiated protocols contain quality research design, and meet DOD standards for ethics and compliance.
- Assist with the amendment of existing investigator-initiated protocols.
- In collaboration with the PI, addresses Scientific Review Committee (SRC), Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and other committee queries.
- Plans and attends committee meetings for disease specific working groups to facilitate research development.
- Assists with managing study development tracking system and enters protocol details and development events in study tracking system.
- Acts as liaison with the data management team, clinical operations team and other research collaborators (as required) 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.
- Collaborates with the correlative research coordinator in the development of specimen submission and management to ensure the specific requirements of the protocols as determined by the project leaders.
- Participates with research and statistical data coordinators, databasedevelopers and database administrators in study database development and data monitoring planning.
- Collects information on reported problems regarding consistency and/or clarity in open protocols.
- Participates in troubleshooting.
- Responsible for initial and updates of study registration on clinicaltrials.gov, including facilitation of QA Review comments.
- Collaborates with other members of any other participating departments to ensure streamlined research compliance
- Participates in the collection of data, supporting both human and animal protocols.
- Assists with other projects as needed.
- Provides education and training on protocol development within and outside department qualifications.
- Doctoral degree in a biological, health science, physiology OR veterinary medicine and three years of relevant research experience; emergency medicine background preferred;
- Master's degree in a biological, health science, physiology OR animal science and five years of relevant research experience; emergency medicine background preferred.
Preference may be given in the technical evaluation to a boarded physician or veterinary professional
- Knowledge of medical terminology and treatment concepts.
- Understanding of national regulations regarding human subjects research.
- Understanding of AAALAC and USDA regulations regarding animal subjects research.
- Demonstrated ability to interact professionally and effectively with investigators, sponsors and cross-functional teams.
- Previous experienceclinical trial protocol writing and editing.
- Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP) and IND requirements.
- Adept at intermediate level biostatistics
- Knowledge of scientific writing, presentation and manuscript presentation.
- Will complete human subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and NMCP research integrity training within one month from start date.