Director - Clinical Trials
Ke`aki Technologies - Honolulu, HI

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CONTINGENT UPON AWARD (CUA)

Ke`aki Technologies, LLC, headquartered in Honolulu, Hawaii, is a Native Hawaiian Organization (NHO) owned business. A premier government services company, Ke`aki Technologies offers a full spectrum of solutions that improve the performance and operational effectiveness of our government and Department of Defense customers. Our mission synchronized solutions are designed to deliver exactly what our customers need, when they need it. From base and range operations to biomedical defense support to telecommunications and IT services, we deliver the exact talent, tools and technologies needed to meet mission requirements.

Ke`aki Technologies has an opportunity for a Director of Clinical Trials in the Department of Clinical Investigation (DCI). It is located at the Tripler Army Medical Center (TAMC). The position requires U.S. Citizenship and completion of a National Agency Check (NAC). This position is contingent upon award.

The Clinical Trials Director will provide clinical trials direction support for the Department of Clinical Investigation (DCI). The Clinical Trials Director will work directly with the PI/designated POC and perform such duties to include, collecting, organizing, maintaining and disseminating patient data files. The successful candidate will conduct clinical studies involving chart reviews, data management, interacting with physicians, nurses, and other research personnel. The Clinical Trials Director will analyze data and summarize findings for incorporation into reports, and prepare oral and written presentations based on data analysis and study summary. Work will include management of clinical trials programs, and development of policies and procedures for clinical study execution and oversight. Work product developed by the contractor is subject to government approval. Review patient records for eligibility in the study, screen study subjects and monitor subjects. Perform statistical data analysis and provide written reports of the findings; and other customary duties performed by a clinical trials director.

ADDITIONAL RESPONSIBILITES INCLUDE:
  • Identify potential clinical trial studies, determine suitability of Tripler AMC patient population based on inclusion / exclusion criteria and required timeline for study completion, and match sponsored studies, clinical coordinators with appropriate Principal Investigator.
  • Assist the clinical coordinator and PI with all Human Use Committee / Institution Review Board (IRB) related requirements and any interface with clinical project collaborators or sponsors as needed.
  • Assemble and coordinate clinical trial study teams of study coordinators and other personnel needed to support the execution of the clinical study.
  • Collect, organize, maintain, and disseminate appropriate files of data as required and assist with administration of the project, writing reports and manuscript preparation.
  • Review patient records and identify potential eligible patients for inclusion/exclusion in the study.
  • Interface with other departments throughout Tripler (e.g. Pharmacy) in support of the clinical protocol. For possible future prospective trials, the contractor shall oversee consent process, monitor and assess patient response therapy. All adverse events will be noted and catalogued.
  • Manage workload for clinical coordinators during studies and interface with physicians and nurses to obtain up-to-date information about the study status. Assure that all reports are completed accurately and in accordance with study sponsor/regulatory requirements.
  • Oversee Clinical Coordinators and PIs that the clinical trial is done in accordance to regulations and protocol design.
  • Provide written reports of analyses which include evaluation of the statistical limitations of the available data and delineation of possible explanations of the findings.
  • For data sets that are considered routine, provide analyses within 1 week if data is provided by the investigator in electronic spreadsheet format. If data is provided as hardcopy and must be entered into a spreadsheet, an additional week is allowed to input the data. For data sets considered emergent, provide analyses within a reasonable time frame, based on workload.
  • Supervise clinical trial activities including clinical monitoring, training, and appropriate management of resources to assure the successful completion of projects.
  • Participate in the planning of new clinical study programs and the development of clinical protocols. Review study protocols to ensure consistency with DCI objectives, regulatory compliance requirements, and adequacy of study design.
  • Oversee the direction, planning, execution, and interpretation of clinical studies and the data collection activities, providing direction, supporting problem identification and resolution.
  • Ensure all clinical studies are conducted according to applicable federal and army regulations and PRMC & TAMC HRPP.
  • Provide ongoing training for investigator teams and develop, communicate and implement research related outreach and training.
  • Interact with other departments to facilitate smooth work processes and communication.
  • Serve as a clinical resource and DCI liaison to other departments and establish and maintain relationships with investigators to optimize clinical trial activities.
  • Assumes lead role for specific protocols serving as primary contact for study related issues
  • Manage government approved study start up activities, including assisting with investigator recruitment, site feasibility, and collection of regulatory documents, IRB submissions and organization and content of investigator meetings
  • Develop relevant study-specific documents
  • Recommend and implement new government approved systems and processes to create efficiencies in clinical trial management.
  • Other duties as assigned.

MINIMUM QUALIFICATIONS:
  • B.S. degree in biomedical sciences or nursing field. ( M.D., Ph.D., or Masters Degree in biomedical sciences or health profession, and certification in the Protection of Human Research Subjects, and Good Clinical Practices is preferred)
  • Minimum of two (2) years of clinical study experience is required
  • Experience with managing investigator-initiated, industry-sponsored, and military research programs; coordination of collaborative partnerships; establishing networks of investigators; and project management is preferred.
  • Research regulatory compliance experience with Institutional Review Board (IRB) approvals, Human Research Protection Plans, Data and Safety Monitoring Boards, and Quality Assurance of Research Execution is preferred.

Job Location: Honolulu, Hawaii (Oahu)

Job Type: Full-Time

FLSA Status: Non-Exempt

Clearance required : National Agency Check (NAC) is required

Ke`aki Technologies LLC is a fast growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid vacation and sick time; and 10 paid holidays.

For additional information on Ke`aki Technologies, LLC, please visit www.keakitech.com .

Ke`aki Technologies, LLC is proud to be an Equal Opportunity Employer/Affirmative Action Employer (EEO/AA) and applicants will be considered without regard to race, color, religion, age, sex, disability, national origin, marital status, or genetic information.