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Job Description

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. All of which has allowed the UW to be nationally recognized as a “Great College to Work For” for five consecutive years.

UW Medicine works to improve the health of the public by advancing medical knowledge, providing outstanding primary and specialty medical care to people of the region, and preparing tomorrow’s physicians, scientists and other health professionals. Within the large UW Medicine health system, the School of Medicine (SoM) is a world leader in biomedical research, with the largest biomedical research program at a public university based on National Institutes of Health funding and ranking among the top research universities internationally.

The Clinical Trials Office (CTO) supports the clinical research mission of UW Medicine. The CTO is an operational unit within the SoM’s Office of Research and Graduate Education (RGE) charged with providing multi-service support to clinical researchers bringing important new therapies to our patients in compliance with evolving regulatory requirements.

The Clinical Trials Office has an outstanding opportunity for a Research Coordinator 3 to support the operations and administration of the Center.

The CTO provides support and education to help investigators improve the quality of their research and ensure compliance with federal, state, and institutional regulations. The CTO Research Coordination Center (RCC) provides support to clinical researchers from the six health sciences schools and others across our partner institutions. The RCC provides assistance with investigator-initiated biomedical or behavioral studies as well as pharmaceutical sponsored clinical trials. The RCC is designed to assist investigators with their research projects by helping with the IRB approval process and the design and implementation of investigator initiated and industry-sponsored research protocols.

This Research Coordinator 3 position works integrally with the Human Subjects Division, Clinical Budgeting and Billing, the Office of Sponsored Projects, and other research support departments such as Investigational Drug Services and the Translational Research Unit within the University. It also interfaces with like positions at Seattle Children's Hospital and Fred Hutchinson Cancer Research Center to create consistent and smooth processes and procedures. This position provides the opportunity to improve the efficiency and compliance of clinical research programs throughout the institutions.

The Research Coordinator 3 interacts with numerous staff, patients, study participants, and faculty. The person in this role must exhibit an appreciation of, a sensitivity to, and respect for, a diverse academic and clinical environment, inclusive of patients, faculty, and staff of many social, economic, cultural, ideological, racial and ethnic backgrounds. The position requires a high degree of flexibility and the ability to work in a variety of settings and locations. The Research Coordinator 3 may work on 4-8 projects simultaneously depending on the complexity of the assignments.

DUTIES AND RESPONSIBILITIES

Research Operations Support** - **65%

+ 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.

Regulatory Support** - **25%

+ 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.

Fiscal Support** - **10%

+ 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.

MINIMUM QUALIFICATIONS

+ Bachelor’s degree in a related field and four years of relevant experience.

+ Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

Additional Requirements:

+ 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.

DESIRED QUALIFICATIONS

+ 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.

WORK ENVIRONMENT

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 will be located at UWMC 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.

Compensation, Benefits and Position Details

Pay Range Minimum:

$80,400.00 annual

Pay Range Maximum:

$87,600.00 annual

Other Compensation:

-

Benefits:

For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/

Shift:

First Shift (United States of America)

Temporary or Regular?

This is a regular position

FTE (Full-Time Equivalent):

100.00%

Union/Bargaining Unit:

UAW Research

About the UW

Working at the University of Washington provides a unique opportunity to change lives – on our campuses, in our state and around the world.

UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty.

Our Commitment

The University of Washington is proud to be an affirmative action and equal opportunity employer (https://hr.uw.edu/eoaa/) . 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 [email protected] .

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 (https://app.leg.wa.gov/RCW/default.aspx?cite=28B.112.080) .

University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.