Clinical Research Protocol Developer

Location
Camp Lejeune, NC
Posted
Dec 07, 2018
Ref
2018-47549
Required Education
Masters Degree/MBA
Position Type
Full time

GDIT is seeking a Clinical Protocol Developer to support the Clinical Investigations Department (CID) at the Naval Medical Center Camp Lejeune (NMCCL). 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.