26 days old

Clinical Protocol Developer

Camp Lejeune, NC 28547
  • Job Code
    R110494

Clinical Protocol Developer,

Naval Medical Center Camp Lejeune, NC

Parsons is seeking a Clinical Protocol Developer (CPD) to support the Clinical Investigations Department (CID) at the Naval Medical Center Camp Lejeune (NMCCL). The individual will provide support to foster and facilitate operationally relevant clinical research programs directed toward enhancing the performance and survivability of military personnel as well as the protection and maintenance of the health of dependents.

NMCCL, CID is engaged in the advancement of scholar activity that is operationally relevant to both the Command and the community. CID currently supports several research efforts to include traumatic brain injury, post-traumatic stress disorder, alternative treatment therapies, prevention and treatment of mental health disorders and military training and readiness.

All efforts support the advancement of knowledge and to better support the warfighter and their families. The newly established Human Research Protection Program (HRPP) is tasked with the responsibility to safeguard and promote the health and welfare of human subjects.

Responsibilities:

  • Work with physicians/scientists to assist in developing, writing, revising, and submitting human subject research protocols, partnering with the PI's to fully develop an idea from the initial research proposal to an ethical and IRB-compliant protocol to submission for publication of results.
  • In consultation with the PI's and the CIDH, prepare new investigator-initiated trials, coordinate the submission, and ensure final product development (presentation and/or publication).
  • In consultation with the PI and CIDH, develop and implement timelines and POA&M's for Government protocol development.
  • Coordinate communication between PI's 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.
  • Conduct literature reviews and draft scientific and technical documents under the direction of the CIDH and PI's.
  • Contribute to the development and modifications of study budgets.
  • Ensure that investigator-initiated protocols contain quality research design, and meet Department of Defense (DoD) and Defense Health Agency (DHA) standards for ethics and compliance.
  • Assist with the amendment of existing investigator-initiated protocols.
  • In collaboration with the PI, address RQC, IRB, and other committee queries.
  • Assist 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 shall prepare and/or review all documents (i.e., protocols/analysis plans/reports/Investigator Brochures/submission pieces). Research results documents are subject to final review/approval by the Government.
  • Participate with research and statistical data coordinators, database developers and database administrators in study database development and data monitoring planning.

Minimum Education Requirements:

  • Bachelor's Degree with a focus in Biology, Healthcare or related discipline (such as Psychology) OR the equivalency of a minimum of three years working experience in a research setting to include a hospital, physician's office, or academic setting, i.e., pre-med student.

Minimum Experience Requirements:

  • A minimum of one year of experience coordinating research protocols as a certified research coordinator; OR certification 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).

Citizenship:

  • US Citizenship is required for this position

Must be able to obtain, maintain and/or currently possess a security clearance.

Categories

Posted: 2020-08-24 Expires: 2020-10-08

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Clinical Protocol Developer

Parsons Corporation
Camp Lejeune, NC 28547

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