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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 Department of Surgery and reports directly to the study PI(s) for research study duties. Administratively, they will report to the Research Manager or respective Division Administrator.
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.
POSITION RESPONSIBILITIES 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 or division administrator 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
REQUIRED QUALIFICATIONS 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
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
Excellent interpersonal skills
Must be comfortable with technology and learning new software
Certified Clinical Research Coordinator (CCRC)
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.
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