Research Coordinator 3 - School of Medicine - Clinical Trials Office

Job Description

The School of Medicine Clinical Trials Office has an outstanding opportunity for a Research Coordinator 3 to join their team.

Reporting to the Manager, Research Coordination Center, the Research Coordinator 3 is responsible for supporting and advancing clinical research studies across UW Medicine and partner institutions. This role partners with investigators, research teams, regulatory offices, and study participants to facilitate high-quality, compliant clinical research. The position offers the opportunity to contribute to innovative research programs that improve patient care while helping researchers navigate complex study start-up, implementation, regulatory, and financial processes.

• Assist investigators and research teams with the start-up and implementation of clinical studies, both industry and investigator-initiated, including obtaining and submitting budget/billing information, implementing the IRB-approved recruitment plan, interacting with research participants, scheduling study visits, gathering data, processing specimens, presenting information to the research team, etc.
• Design, create, and revise research documents as necessary to ensure quality data that correlate with research objectives; coordinate multiple protocol-specific data collection efforts for one or more research projects which may include other collaborating agencies or institutions.
• Consult with investigators on appropriate management of participant problems and concerns; troubleshoot acute individual or departmental research issues.

• Obtain and maintain IRB approval for investigators (create and submit IRB applications for minimal risk, standard studies, medical record review, repositories, etc.) from the UW IRB, FHCRC IRB, Western IRB, VAPSHCS IRB, Seattle Children's IRB, and other IRB's as required.
• Oversee regulatory, budgetary, contractual, and all other aspects of protocol implementation, ensuring compliance with applicable federal regulations, institutional policies, and the principles of Good Clinical Practice (GCP).
• Report and document safety issues (e.g. adverse events).
• Prepare for and participate in sponsor audits and/or regulatory inspections, if applicable.

• Consult with faculty to determine accurate cost projections for industry and federally funded research protocols.
• Work with the central CTO Budgeting Team to develop adequate budgets for industry-sponsored trials and help investigators develop reasonable budget projections for federally sponsored protocols.
• Provide adequate review of study billing grids and perform required OnCore CTMS and Epic EMR-based workflows to ensure proper billing of research subjects.
• Work with the central CTO Billing Team to review invoices for hospital and professional services and resolve any disputes.
• Other duties and training as required.

To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

• Bachelor's degree in a related field and four years of relevant experience.

Applicants who do not meet these qualifications WILL NOT be forwarded to the Hiring Manager.

• Excellent written and verbal communication, including patient interactions, consulting, and customer service skills.
• Proficiency with standard MS Office software, including Word, Excel, Access, and Power Point.
• Strong internal and external customer service skills.
• Ability to adapt and respond appropriately to competing priorities in a fast-paced environment.
• Self-motivated, self-starter who takes initiative to improve existing processes.

• Medical Assistant or phlebotomy certification in the State of Washington.
• Fluency in a language other than English.
• Experience with community engagement.
• Experience with project management or CPI training.

This role requires performing assignments for investigators on a temporary or limited term basis. The role also requires the ability to navigate effectively through the many regulatory rules and specific regulations within the University of Washington in order to expedite clinical research start-up and implementation. The Research Coordinator 3 will be located at the University of Washington Medical Center but may work at a variety of sites depending upon the location of a specific project.

Work sites for this position may include the University of Washington Medical Center, Montlake, University of Washington Medical Center, Northwest, Harborview Medical Center, Seattle Cancer Care Alliance, South Lake Union and UW Neighborhood Clinics.

The School of Medicine Clinical Trials Office (CTO) supports the clinical research mission…