RESEARCH STUDY COORDINATOR
University of Washington Bothell
RESEARCH STUDY COORDINATOR | ||||||||||||||||||||||||||
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As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills, and dedication to build stronger minds and a healthier world. UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits, and natural beauty. The Division of Hematology & Oncology has an outstanding opportunity for a Research Study Coordinator to join their team. POSITION PURPOSE The UW Medicine Cancer Vaccine Institute has an excellent opportunity for a full time Research Study Coordinator 2 to work within our CVI Clinical Core. Under the general direction by the Director of Regulatory Affairs, this individual will provide study design support of the implementation and optimization of current clinical trials. This role requires experience and proficiency in protocol development, regulatory compliance, and data integrity management with independent decision-making authority. DUTIES AND RESPONSIBILITIES Study Design & Protocol Development: • Develop and implement standardized guidelines, procedures and forms for data collection, subject population identification, and quality assurance for research studies. • Recruit, interview, and pre-screen potential subjects and determine eligibility according to established criteria under general supervision. • Identify and resolve operational challenges to maintain protocol adherence. • Assist in the design of studies and review proposals to determine appropriate research methods. • Prepare template clinical case report forms (CRFs), consent forms, and other required forms for scheduled clinical visits. • Extract technical, medical and/or behavioral information from institution or clinical records. • Interpret and record research subject self-reported data using CRFs and established rating scales or criteria under the direction of the Research Manager. • Receive human clinical trial specimens obtained during visits and provide specimens to CVI’s Immune Monitoring Laboratory per established SOPs. • Establish and maintain relationships with community physicians and clinics to expand recruitment catchment. • Develop and distribute materials for recruitment and engagement with community clinics. • Maintain adherence to research protocols and verify accuracy of research study data. • Implement research protocols and monitor participant adherence, take corrective action for deviations. • Write relevant sections for research grants (i.e. recruitment plans, data dissemination and human subjects’ sections). Regulatory & Compliance: • Generate initial drafts of human subjects’ applications, consent forms and progress reports for institutional review board. • Serve as regulatory point of contact for sponsors, monitoring agencies, and participating sites. • Develop and maintain audit-ready regulatory binders and monitoring plans. • Initiate study start-up activities in our institutional system (OnCore). Data Management & Analysis: • Use existing database management programs to analyze data and prepare summary narrative reports, graphs, tables, charts and illustrations for internal distribution. • Perform data analysis using GraphPad Prism statistical program. • Prepare scientific reports with visualizations of key findings for publications. • Assist in the design of and validate electronic data capture systems tailored to study needs. • Enter CRF data into established clinical database(s), organize and check data for quality, accuracy, and completeness, and monitor data quality control to ensure adherence to study protocol. • Be the primary point of contact on regulatory topics with the remaining trial coordination team. • Assist in the review of study vaccination schedules and modify schedules as needed; inform participants of schedule changes. Required Qualifications • A Bachelor’s degree in a relevant academic area AND two years of experience coordinating the operations of clinical, biomedical, or behavioral research studies involving human subject. Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. DESIRED QUALIFICATIONS • Experience in immunology and oncology research. • Prior experience with protocol development, regulatory compliance and data integrity management. • Highly organized. • Experience in patient interactions and clinical conduct. • Demonstrated the history of utilizing and navigating MS Access databases to prepare reports, charts, and tables for internal distribution. • Form productive working relationships with co-workers. • Open to receiving feedback and making constructive changes as a result. • Open to receiving directions and ask for assistance when needed. • Demonstrate a courteous, respectful, professional attitude and behavior at all times. • Represent the group professionally. • Excellent written and oral communication skills; including ability to write and present data orally. • Strong interpersonal skills, with the ability to work effectively within an established team environment. • Ability to communicate, interact and address questions with a variety of stakeholders (i.e. physicians, patients, participating sites, UW departments such as pathology). CONDITIONS OF EMPLOYMENT The Cancer Vaccine Institute is located at the UW Medicine at South Lake Union campus in a translational research environment that includes laboratory, clinical research and administrative office areas. Work is typically deadline driven and requires a high level of accuracy, and extensive communication with clinicians, scientists, staff and patients from diverse backgrounds. Must be flexible and able to work evenings, weekends and holidays as necessary. #UWDeptMedicineJobs | ||||||||||||||||||||||||||
Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming. The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information. To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu. Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law. | ||||||||||||||||||||||||||