General Dynamics Information Technology Clinical Protocol Developer in Camp Lejeune, North Carolina
GDIT is seeking a Clinical Protocol Developer to support theClinical Investigations Department (CID) at the Naval Medical Center Camp Lejeune.The Clinical Protocol Developer will provide technical, administrative, and scientific support to assist with the development, writing, revision, IRB submission, and publication of investigator-initiated protocols and clinical trials at NMCCL. This position will partner with the Primary Investigator (PI) to fully develop an idea from the initial research proposal letter of intent stage to an ethical and IRB-compliant protocol that can be successfully executed at NMCCL, and to submission for publication of the protocol's results. It is the CPD's role to oversee all report writing activities for the projects they are supporting.
In consultation with the PI's and the CID, prepares new investigator-initiated trials, develops timelimes, coordinates the submission, and ensures final product development (presentation and/or publication).
Responsible for coordinating communication between PIs and command and research leadership, other research support such as biostatisticians and basic scientists who are part of the various working groups, and collaborating agencies or institutions for the purpose of protocol development and final research publication.
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 CID and PIs.
Contributes to the development and modifications of study budgets.
Ensure that investigator-initiated protocols contain quality research design and meet DoD and DON 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 different clinical departments and disease specific working groups to facilitate research development.
Assists Research Administration Officer (RAO) with managing study development tracking system and enters protocol details and development events in study tracking system.
Collaborates with the corresponding research nurse/coordinator/assistant in the development of specimen submission and management plans 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.
Participates in troubleshooting administrative procedures and problems and assists in developing Standard Operating Procedures, desktop procedures, and best practices for the purpose of protocol development and final research publication.
Responsible for initial and updates of study registration on clinicaltrials.gov, including facilitation of QA Review comments.
Participates in the collection of data supporting human research protocols.
Assists with the preparation, writing, editing, revising, and submission of the research results for scholarly publication and presentation at scientific and professional meetings. The CPD must ensure consistency across documents and improve overall document quality. The CPD will prepare and/or review all final documents (i.e., protocols/analysis plans/reports/Investigator Brochures/submission pieces).
Provides education and training on protocol development to members of the research team, PIs/AIs, other designated research personnel, and NMCCL staff.
Attends seminars, workshops, and conferences in order to gain insight into new trends in human research, improve effectiveness and efficiency in their primary duties, and to learn new approaches for the application of federal regulations.
A Masters degree (or higher) in a biological, health/medical science, behavior health, physiology, or nursing background is preferred.
5-8 years of related experiencein developing, writing, revising, and submitting human subject research protocols. Years of experience may be supplmented bycertification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).
Demonstrated knowledge and previous experience in clinical trial protocol writing and editing, including developing an idea from the initial research proposal to an ethical and IRB-compliant protocol to submission for publication of results as demonstrated by the successful management of completed human subject research protocols and publication in peer reviewed literature.
Knowledge of medical terminology and treatment concepts.
Knowledge of applicable Department of Defense (DoD), Department of the Navy (DoN), Health and Human Services (HHS), Food and Drug Administration (FDA) policies, guidelines and regulations, and federal and state laws pertaining to the use of human subjects in research - to include the use of investigative drugs/devices.
Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP) and IND/IDE requirements.
Adept at intermediate level biostatistics.
Knowledge of scientific writing, presentation and manuscript presentation.
Skill in using desktop and networked computer software, to include intermediate or advanced level competencies with Microsoft Windows, and the Microsoft Office suite (Outlook, Word, Excel). Ability to learn and master proprietary software such as EIRB, ProIRB, PROMIS and IRBNet protocol data management software, as these programs are critical to the day-to-day operations of the CID.
Sufficient personal and professional skills to conduct collaborations with scientific researchers and to participate with higher authorities and colleagues in a variety of settings. Skill in delivering recommendations that may be disputed to a varied group of managerial and professional staff.
Ability to communicate orally and in writing with all levels of the organization. Effective, accurate, timely, and tactful communication are essential to the proper function of the department.
The work is largely sedentary, requiring long periods of sitting, reading, and mental concentration. The work involves some walking between offices and buildings. There is some, stooping, short periods of standing, and carrying of light items such as papers, files, and books between offices and buildings. Driving between buildings/sites may be necessary.
For more than 50 years, General Dynamics Information Technology has served as a trusted provider of information technology, systems engineering, training and professional services to customers across federal, state, and local governments, and in the commercial sector. Over 40,000 GDIT professionals deliver enterprise solutions, manage mission-critical IT programs and provide mission support services worldwide. 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.
Job FunctionScience and Engineering
Security Clearance LevelNone
Full/Part TimeFull Time