The Study Coordinator I provides non-personal services of Study Coordinators to specific clinical or translational studies and shall provide input to the Principal Investigator (PI)/designated point of contact (POC) for the Department of Clinical Investigation. The position will manage multiple clinical and translational studies simultaneously and develop policies and procedures for clinical study execution and oversight. All duties and responsibilities performed in accordance with the Mission, Vision and Core Values of Cayuse.

• Supports the Department of Clinical Investigation (DCI), Tripler Army Medical Center (TAMC), working directly with the Chief or Deputy Chief of DCI, Principal Investigator (PI) of the study and/or designated POC.
• Perform duties to include, but not limited to, collect, organize, maintain and disseminate patient data files. Review patient records for eligibility in the study, screen subjects and monitor them throughout the course of the study. Prepare files for statistical data analysis and provide documentation for written reports of the findings
• Identify potential clinical trial studies, determine suitability of TAMC patient population based on inclusion/exclusion criteria and required timeline for study completion, and match sponsored studies with appropriate PI.
• Assist the PI and Study Coordinator Level II, with all Human Use Committee / Institution Review Board related requirements and any interface with clinical project collaborators or sponsors.
• Assist with assembling and coordinating clinical trial study teams of study coordinators and other personnel needed to support the execution of the clinical study.
• Assist with the collection, 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 trials, oversee consent process, monitor and assess patient response therapy. All adverse events will be noted and catalogued.  Follow patient course during study and interface with physicians and nurses to obtain up-to-date information about the patient's status. Assure that all case reports are completed accurately and in accordance with study sponsor requirements.
• Assist with the retrieval of 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. Logs of patients in the study and collected data will remain confidential.
• 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 one (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.
• Other duties as assigned

Minimum Qualifications:

• Bachelor of Science in biomedical science field or four (4) years' experience working in biomedical research programs.
• Minimum two (2) years clinical study experience.
• One (1) year of experience in managing investigator-initiated, industry-sponsored, and military research protocols.
• One (1) year of experience with coordination of collaborative partnerships, establishing networks of investigators, and project management.
• 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.
• Evidence of ability to conduct a preliminary clinical study including the following: chart reviews, data management, interacting with physicians, nurses, and other research 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 documentation for multiple clinical trials, develop policies and procedures for clinical study execution and oversight.
• Research regulatory compliance experience with Institutional Review Board approvals, Human Research Protection Plans, Data and Safety Monitoring Boards, Quality Assurance of Research Execution.
• Familiarity with statistical analysis and use of electronic protocol processing
• Must be able to pass a background check. May require additional background checks as required by projects and/or clients at any time during employment.

Minimum Skills:

• Strong interpersonal skills with the ability to communicate in a professional, and articulate manner to individuals from diverse backgrounds.
• Excellent verbal and written communication.
• Excellent organizational, analytical, and problem-solving skills with high-level attention to detail.
• Proven ability to multitask and prioritize in a fast-paced environment with changing priorities; adaptable to change and a quick learner.
• Must be self-motivated and able to work well independently as well as on a multi-functional team.
• Ability to handle sensitive and confidential information appropriately.
• Must be computer literate with proficiency and working knowledge of common database and reporting tools.

Reports to: Program Manager

Working Conditions:

• Professional office environment.
• Must be physically and mentally able to perform duties for extended periods of time. Ability to use a computer and other office productivity tools with sufficient speed to meet the demands of this position.
• Must be able to establish a productive and professional workspace.
• Must be able to work varying work schedules and/or extended hours to meet business needs and project deadlines.
• May be asked to travel for business or professional development purposes.

Other Duties: Please note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job.  Duties, responsibilities, and activities may change at any time with or without notice.

Affirmative Action/EEO Statement: Cayuse Holdings (and all its subsidiaries) is an equal opportunity employer.  We celebrate diversity and are committed to creating inclusive employment for all employees.