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Clinical Protocol Developer

Location NC - Camp Lejeune

Job Code 13002

# of openings 1

The Alaka`ina Foundation Family of Companies (FOCs) is possibly looking for a Clinical Protocol Developer to provide research support administration services for our government customer at Camp Lejeune, NC.

DESCRIPTION OF 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).

+ Participate with research and statistical data coordinators, database developers and database administrators in study database development and data monitoring planning.

+ Other duties as assigned by Supervisor.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

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.

REQUIRED SKILLS AND EXPERIENCE:

+ 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).

REQUIRED CITIZENSHIP AND CLEARANCE:

+ Must be U.S. Citizen

+ Must pass a NACI background check and be eligible for a CAC card.

The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees

•EOE, including Disability/Vets” OR “Equal Opportunity Employer, including Disability/Veterans”

The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kapili Services, Po`okela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

For additional information, please visit www.alakainafoundation.com

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