Clinical Protocol Developer
Description
Clinical Protocol Developer
About CICONIX: CICONIX LLC is a Veteran Owned Small Business specializing in business advisory and technical assistance for military health programs. We value exceptional people, unwavering integrity, inclusive collaboration, and enduring impact.
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Location(s): Jacksonville, NC (on-site) | Camp Lejeune
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Position Offers:
- Full-time/long-term position
- Regular weekly hours & flexible work schedule (0700-1700)
- No calls, nights, weekends, or holidays!
- Full benefit program, including: health, PTO, and 401k + contribution
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Requirements:
- Bachelor's Degree
- One (1) year of experience coordinating research protocols as a certified research coordinator
Summary:
CICONIX is seeking a Clinical Protocol Developer to support the Clinical Investigations Department (CID), Directorate of Professional Education (DPE), Naval Medical Center Camp Lejeune (NMCCL) team in Jacksonville, North Carolina.
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About the Role:
- 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).
- Participate with research and statistical data coordinators, database developers and database administrators in study database development and data monitoring planning.
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Qualifications:
- Education:
- 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.
- Experience:
- A minimum of one (1) 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).
- Security & Background Check:
- U.S. Citizenship and a successful background investigation are required.
- Ability to obtain and maintain a government security clearance.
- Additional Requirements:
- N/A
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Compensation: TBD
CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E-Verify all employees.