University of Washington   Seattle, WA   Full-time     Research
Apply Now
Posted on May 18, 2020
Req #: 178027
Department: SURGERY
Job Location: Health Sciences Center
Posting Date: 03/19/2020 
Closing Info: Open Until Filled 
Salary: Salary and benefits are competitive. Salary is commensurate with qualifications and experience. 
Shift: First Shift 
Notes: As a UW employee, you will enjoy generous benefits and work/life programs.  For detailed information on Benefits for this position, click here.  

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 six consecutive years.

The purpose of this position is three-fold: to provide administrative direction and coordination for clinical trials on the UW campus; to coordinate the implementation, operation and closing procedures for one or more research studies; and, to maintain regulatory and protocol compliance for studies on the UWMC campus. This position works in the Vascular division within the Department of Surgery and reports directly to the study PI(s) for research study duties. Administratively, they will report to the Research Manager.

The individual in this position will be the first person a patient interacts with when contemplating becoming part of a research study. Professional, patient-centered interactions with potential participants is very important to the success of a study. A key responsibility for this position is to be an advocate for the patient and work diligently to assure the safety of the patients through responsible conduct of the research. The ideal candidate will have the skills and abilities required to instill confidence in the PIs, sponsors, and administrative partners they work with.

Details of major job duties include:
Human Subjects Research Activities – 50%
Administrative Coordination - 25%
Regulatory and Compliance Management – 25%

Research Coordinators at this level have increasingly complex roles and responsibilities. The nature of the work requires that this individual have a high level of independence, be self-motivated and able to take initiative. This individual must be inherently ethical, willing and capable of abiding by the multitude of compliance regulations associated with conducting research with human subjects.

Clinical research is a vital component of the Research arm of the University’s mission. This is where bench research meets patient need and results in important new processes, devices or medicine that improve the health of the population.

The UW Medicine Regional Vascular Center provides comprehensive services for patients with circulatory problems and their referring healthcare providers throughout a five-state region: Washington, Wyoming, Alaska, Montana and Idaho (WWAMI). Our vascular experts in arterial, venous, and lymphatic disease work with radiology and cardiology specialists to determine the appropriate diagnostic imaging and medical or surgical treatment options. As a regional resource, we provide care that is not available in smaller communities. The center treats more patients with ruptured abdominal aortic aneurysms (rAAA) annually than any other healthcare facility in the WWAMI region and we have also been internationally recognized for creating an emergency protocol that dramatically reduced the average mortality rate for rAAA patients.

Human Subjects Research Activities 50%
  • Appropriately screen, recruit, consent, enroll and track subjects over time according to requirements noted in the research protocol and in compliance with regulatory and institutional requirements for research studies;
  • Successfully ensure that industry sponsored research projects stay on time and on-budget with projected project goals and contractual terms;
  • Effectively partner with Principal Investigators (PI’s) to ensure all aspects of industry sponsored clinical trials are completed accurately, professionally and timely;
  • Carefully monitor study patient follow-up visits and ensure subjects are scheduled according to the research protocols; take appropriate action to correct problems or deviations that may arise;
  • Ensure all adverse events and serious adverse events are promptly reported to PI, sponsor and the IRB according to the protocol;
  • Complete Case Report Forms (CRFs) and data entered in sponsor electronic data base as indicated in the protocol;
  • Serve as liaison between the project team, industry and other stakeholders, including UWMC staff and health care providers.  Keep parties apprised of study progress as appropriate;
  • Effectively complete detailed analysis of clinical research projects and provide summary, including any concerns to CRBB, OSP, the School of Medicine (SOM), practice site staff, investigators and their research staff;
  • Effectively monitor customer feedback, including internal Department of Surgery customers, University customers such as OSP, and sponsors;
  • Notice and implement improvements to the customer service aspect of the program as needed

    Administrative Coordination 25%
  • Successfully submit accurate and timely UW IRB/WIRB applications, renewals or modifications and informed consent documents;
  • Establish well organized, systematic, thorough research files both paper and electronic; ensure on-going file management
  • Manage monitoring visits from sponsors;
  • Assist with development and monitoring of project budgets, as well as ensuring closure of budgets as needed;
  • Alert the Research Manager to any budget problems or concerns that occur; work with appropriate parties to rectify issues;
  • As necessary, provide accurate and timely invoicing of sponsor;
  • Assist with preparing and finalizing progress reports to send to agencies;

    Regulatory and Compliance Management 25%
  • Know and follow all FDA, NIH and University of Washington IRB requirements and ICH GCP guidelines relating to research involving human subjects;
  • Effectively manage all regulatory submissions (UW HSD, WIRB, device/CMS approval documents, etc.) and regulatory compliance issues
  • Effectively oversee and manage systems that produce research study adherence to all regulations controlling outcomes and clinical research (i.e., human subjects regulations, UW policies/guidelines, coding standards and other institutional policies and standards)
  • Effectively ensure all study participant information is provided in compliance with applicable privacy regulations
  • Is or is becoming an expert on research compliance, particularly compliance around industry-sponsored trials

    Education: Bachelor's degree in health care management, biology, chemistry, microbiology, or related;
    Type and Years of Experience: At least 2 years of experience with clinical studies and/or industry sponsored research in a medical setting or equivalent combination of work and experience

  • Experience with IRB submissions, modification, and renewals
  • Knowledge of medical terminology
  • Good Clinical Practice (GCP) and Human Subject Protection (HSP) Training
  • Proficient with Microsoft Office Suite (Word, Excel, Outlook, etc.)
  • Demonstrated ability to work independently, under supervision, and within a team
  • Excellent written and verbal communication skills
  • Strong attention to detail
  • Ability to multi-task and strong organizational abilities
  • Excellent interpersonal skills
  • Must be comfortable with technology and learning new software

  • Certified Clinical Research Coordinator (CCRC)
  • IRB experience

    Application Process:
    The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process.  These assessments may include Work Authorization, Cover Letter and/or others.  Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.
  • 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 a leader in environmental stewardship & sustainability, and committed to becoming climate neutral.

    The University of Washington is an equal opportunity, affirmative action employer. To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 / 206-543-6452 (tty) or