Clinical Protocol Manager/Writer
General Dynamics IT is currently looking for an experienced Clinical Protocol Developer/Writer to join our team to support the Naval Medical Center in Portsmouth, VA
The Clinical Protocol Developer will provide technical and scientific support for the development and execution of investigator-initiated protocols and clinical trials at NMCP. This position will partner with the Primary Investigator (EMD) to fully develop an idea from the letter of intent (LOI) stage to an ethical and IRB/IACUC-compliant protocol that can be successfully executed at NMCP. Tasks include:
- Works with physicians/scientists to assist in developing, writing and producing human and animal research protocols that are within the scope of the Combat Casualty Care Program and NMCP's Combat Trauma Research Group (CTRG)
- In consultation with the principal investigators (PI's) and the CTRG director, prepare 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 CTRG Director and PIs.
- 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), 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, database developers 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 the EMD and 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.The Government reserves the right to review, approve, and confirm qualifications.
- Doctoral degree in a biological, health science, physiology OR veterinary medicine and three years of relevant research experience; emergency medicine background preferred; Preference may be given in the technical evaluation to a boarded physician or veterinary professional OR Master's degree in a biological, health science, physiology OR animal science and five years of relevant research experience; emergency medicine background preferred.
- 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 experience clinical 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.
As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.