Study Coordinator II

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Updated: June 20, 2019
Job ID: 214915
Status: Full-Time
Regular/Temporary: Regular
Location: Honolulu, HI, United States

Join the HJF Team!

The Henry M. Jackson Foundation (HJF) is looking for a Study Coordinator to support the Department of Clinical Investigation (DCI) at Tripler Army Medical Center (TAMC) in Honolulu, Hawaii which shall support clinical and translational studies. The Study Coordinator will work directly with the PI/designated POC and perform such duties to include, but not limited to: collecting, organizing, maintaining and disseminating patient data files, reviewing patient records for eligibility in the study; screen study subjects, enrolling subjects, and monitoring subjects; obtaining specimens for laboratory analysis; performing statistical data analysis and provide written reports of the findings.
JOB DUTIES:       
1. Identify potential clinical or translational studies, determine suitability of Tripler AMC patient population based on inclusion / exclusion criteria and required timeline for study completion, and match sponsored studies with appropriate Principal Investigator. 
2. Provide input to the PI with all Scientific Review and Institution Review Board related requirements and any interface with clinical project collaborators or sponsors. 
3. Assemble and make recommendations for clinical and translational study teams of study coordinators and other personnel needed to support the execution of the clinical study.
4. Collect, organize, maintain, and disseminate appropriate files of data as required and administer the project, writing reports and preparing manuscripts.
5. Review patient records and identify potential eligible patients for inclusion/exclusion in the study.  Help with study subject enrollment, obtain specimens for laboratory analysis. 
6. Interface with other departments throughout Tripler (e.g. Pharmacy) in support of the clinical or translational study.  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.   For translational laboratory or animal model studies, the Study Coordinator shall provide specimen collecting and processing. 
7. Follow study subject course during study and interface with physicians, nurses and technicians to obtain up-to-date information about the study subject's status.  Assure that all case reports are completed accurately and in accordance with study sponsor requirements.
8. Retrieve appropriate data from patient's written and electronic medical records and extract patient information from computer data base, x-ray results, and laboratory/culture results, inputting this data into appropriate forms.  Assure that logs and collected data from patients enrolled in the study remain confidential.
9. Provide written reports of analyses which include evaluation of the statistical limitations of the available data and delineation of possible explanations of the findings.
10. For data sets that are in electronic spreadsheet format, provide analyses within 1 week.  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 2 day time frame.

Required Knowledge, Skills, and Abilities:  Evidence of ability to conduct clinical and translational studies including the following: chart reviews, specimen processing, data management, interacting with physicians, nurses, and other laboratory personnel. Ability to analyze data and summarize findings for incorporation into reports. Must be able to prepare oral and written presentations based on data analysis and study summary. Demonstrated ability to manage multiple clinical and translational studies, develop policies and procedures for clinical study execution and oversight.

Education/Training Requirements: 
• Minimum of a Bachelor's degree in related discipline.
• Familiarity with statistical analysis. 

• Minimum of 4 to 6 years of clinical or laboratory study experience. 
• Preferred experience in managing investigator-initiated, industry-sponsored, or military studies. 
• Extensive experience with coordination of collaborative partnerships, establishing networks of clinical and laboratory investigators, project management and laboratory analyses. 
• Experience with computers, to include ability to use Word and Excel, ability to retrieve information from computerized data system, development of tracking systems and maintenance of data and research records.
• Research regulatory compliance experience with Institutional Review Board approvals, Human Research Protection Plans, Data and Safety Monitoring Boards, Quality Assurance of Research Execution

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check. 

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.