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University of Washington
Seattle, WA Full-time
Posted on January 2, 2020
Req #: 174354
Job Location: Health Sciences Center
Posting Date: 12/02/2019 
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 within the Department of Surgery and reports to the Senior Research Coordinator with a highly matrixed relationship to the Study PI’s.

Details of major job duties include:
Conducting research that involves human subjects; i.e., personally, or in an oversight capacity, screening, recruiting, consenting, interviewing and performing steps in research protocol on human subjects for multiple assigned research projects = 50%
Administrative and compliance management of research projects; i.e., preparation of IRB submissions (applications, renewals, or modifications); management of research data files (paper and electronic); communication with sponsor, including submission of CRFs, response to queries and preparation of progress reports; participation in monitoring visits = 40%
Planning and executing closure of research projects; i.e., finalizing reports to agencies, assuring closure of budgets, assuring on-going management of data files = 10%

The individual in this position is generally 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. Importantly, the individual in this role is an advocate for the patient and works diligently to assure the safety of the patients through the responsible conduct of the research. The successful Coordinator will demonstrate skills and abilities that instill confidence in the patients. The Coordinator works with, PIs, Patients, the sponsors, and the administrative partners.

Research Coordinators at this level have increasingly complex roles and responsibilities. The nature of their work requires that this individual have a high level of independence and know how to 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.  One important device trial that was tested and brought into mainstream medicine was “heart in a box.” This device allows surgeons to travel to retrieve an organ up to 12 hours away.  The first patient trialed to use this in the WWAMI region was at University of Washington, through the Cardiothoracic Surgery Division, Department of Surgery.

Conduct of Research involving Human Subjects = 50%

The individual in this position must have a thorough understanding of the trial protocol and of what is required to implement this protocol in the healthcare system.  They must be able to plan, communicate and manage details for successful execution.  The individual in this role is an advocate for the patient and works diligently to assure the safety of the patients through the responsible conduct of the research.
Duties include:
  • 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 manage industry sponsored research projects; ensuring they stay on time and on-budget with projected project goals and contractual terms;
  • Effectively partnering with Principal Investigators (PI’s) to assure all aspects of industry sponsored clinical trials are completed accurately, professionally and timely;
  • Assure all adverse events and serious adverse events are promptly reported to sponsor and the IRB according to the protocol;
  • Carefully monitor study patient follow-up visits and assure subjects are scheduled according to the research protocols; take appropriate action to correct problems or deviations that may arise;
  • Complete Case Report Forms and data entered in sponsor electronic data base as indicated in the protocol;
  • Serving as liaison between the project team, industry and other stakeholders, including UWMC staff and health care providers.  Keeps parties apprised of study progress as needed;
  • Effectively completing detailed analysis of clinical research projects and providing summary including any concerns to CRBB, OSP, the School of Medicine (SOM), practice site staff, investigators and their research staff;
  • Effectively monitoring customer feedback (including internal Department of Surgery customers, University customers such as OSP, and sponsors);
  • Noticing and implementing improvements to the customer service aspect of the program as needed;
  • Oversee or complete accurate and timely invoicing of sponsor as necessary;
  • Alert Division Administrator and PI to any budget problems or concerns that occur; work with Division Administrator and appropriate University bodies to rectify budget problems;
  • Oversee and give direction to more junior staff and/or student interns in the conduct of particular research activities.

    Administrative and Compliance Management of Research Projects =40%
    The individual in this position is responsible, with the PI, for assuring that the research project is compliant with all regulations, is meticulously documented and that all required communication is completed in an accurate and timely manner.  They are responsible to work with the Administrator on fiscal management of the trial.  Duties include:
  • Know and follow all FDA, NIH and University of Washington IRB requirements and ICH GCP guidelines relating to research involving human subjects;
  • Complete required trainings, as designated by the UW School of Medicine and/or the Department of Surgery, within determined timeline;
  • Effectively managing all regulatory submissions (UW HSD, WIRB, device/CMS approval documents, etc) and regulatory compliance issues;
  • Successfully submitting accurate and timely UW IRB/WIRB applications and informed consent documents;
  • Is an expert on research compliance, especially compliance around industry-sponsored trials;
  • Effectively ensuring all study participant information is provided in compliance with applicable privacy regulations;
  • Establish well organized, systematic, thorough research files (paper and electronic); assure these files are strictly maintained
  • Manage monitoring visits from sponsors;
  • Effectively overseeing and managing 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);

    Closing Research Projects = 10% 
    The individual in this position is responsible, with the PI, for planning and executing closure of research projects; i.e., finalizing reports to agencies, assuring closure of budgets, assuring on-going management of data files. Duties include:
  • Complete all documentation to sponsors and others associated with finishing a research project in a timely and thorough manner;
  • Determine project data storage needs; ready files for storage or further use in other projects;
  • Assure required reports are filed with all appropriate bodies, including regulatory agencies and sponsors

    BA or BS in field of study such as health care management, biology, chemistry, microbiology, or related;
    Type and Years of Experience: 3-4 Years’ of experience in research setting, with 1-2 years of clinical and/or industry sponsored research

    Other Required Qualifications
  • 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
  • Ability to implement all FDA/GCP/HSP guidelines
  • Excellent interpersonal skills
  • Must be comfortable with technology and learning new software
  • Willingness to participate in evening, night, weekend call if studies require it

    Desired Qualifications
  • Certified Clinical Research Coordinator (CCRC), highly desirable
  • Experience with FDA audits
  • Experience with clinical trials in cardiothoracic surgery, vascular surgery, or cardiology

    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