Primary Focus:

Provide Study Coordinator services to government led clinical and translational studies. The Study Coordinator will work directly with the Principal Investigator/designated POC and perform duties to include collecting, organizing, maintaining, and disseminating patient data files, reviewing patient records for eligibility in the study; screening study subjects, enrolling subjects and monitoring subjects; obtaining specimens for laboratory analysis; performing statistical data analysis and provide written reports of the findings. This position performs all duties and responsibilities in accordance with the Mission, Vision, and Core Values of Cayuse.

• Contractor shall identify potential clinical or translational studies and determine suitability of TAMC patient population based on inclusion / exclusion criteria and required timeline for study completion
• The Contractor shall match sponsored studies with appropriate Principal Investigator
• The Contractor shall provide input to the Principal Investigator with all Scientific Review and Institutional Review Board related requirements and any interface with clinical project collaborators or sponsors
• The Contractor shall 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.
• The Contractor shall collect, organize, maintain, and disseminate appropriate files of data as required and administer project, writing reports and preparing manuscripts
• The Contractor shall review patient records and identify potential eligible patients for inclusion/exclusion in the study. The Contactor shall provide input to study subject enrollment, obtain specimens for laboratory analysis
• The Contractor shall interface with other departments throughout TAMC (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. The Contractor shall ensure that all adverse events are noted and catalogued. For translational laboratory or animal model studies, the Study Coordinator shall provide specimen collecting and processing
• The Contractor shall 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. The Contractor shall assure that all case reports are completed accurately and in accordance with study sponsor requirements
• The Contractor shall 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
• The Contractor shall assure that logs and collected data from patients enrolled in the study remain confidential
• The Contractor shall provide written reports of analyses which include evaluation of the statistical limitations of the available data and delineation of possible explanations of the findings. Provide other written progress reports, deviation reports, continuing review reports, and updating of protocol approval documents as needed
• For data sets that are in electronic spreadsheet format, the Contractor shall provide analyses within one week. If data is provided as hardcopy and must be entered into a spreadsheet, an additional week is allowed to input the data
• Other duties as assigned.

Minimum Qualifications:      

• Must have a Bachelor of Science in biomedical science field or nursing
• Minimum 6 years or successful execution of over 30 clinical trial studies or collaborative biomedical laboratory study experience (Study Coordinator II)
• Research regulatory compliance experience with Institutional Review Board approvals, Human Research Protection Plans, Data and Safety Monitoring Boards, Quality Assurance of Research Execution
• 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:

• Resume or curriculum vitae which reflects ability to conduct clinical and translational studies including the following: chart reviews, specimen processing, data management, interacting with physicians, scientists, 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 (as reflected in resume by publications, posters or podium presentations at national conferences, delivery of lectures or scientific presentations, thesis) based on data analysis and study summary
• Demonstrated ability (i.e., former work history of managing multiple research studies or clinical trials) to manage multiple clinical and translational studies simultaneously, and develop policies and procedures for clinical study execution and oversight
• 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
• Familiarity with statistical analysis and preparing manuscripts for publication

Preferred Qualifications:

• Preferred experience in managing investigator-initiated, industry-sponsored, or military studies
• Preferred more than 5 years’ experience with coordination of collaborative partnerships, establishing networks of clinical and laboratory investigators, project management and laboratory analyses
• Preferred Biomedical post baccalaureate degree with clinical or translational study experience: M.D., Ph.D., or master’s degree in biomedical sciences or health care profession

 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.
• Will be required to attend and conduct virtual meetings throughout the workday
• 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 embraces diversity and equal opportunity in a serious way. We celebrate diversity and are committed to creating and building a team that represents a variety of backgrounds, perspectives, and skills. Cayuse, and all of its subsidiaries, are proud to be an equal opportunity workplace and are an affirmative action employer.