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UW’s Divisions of Cardiothoracic and Vascular Surgery, part of the UW School of Medicine’s Department of Surgery, has an exciting opportunity for a 1.0 FTE Research Coordinator to coordinate a cutting-edge investigational device exemption (IDE) trial at Harborview Medical Center.
This position will specifically coordinate the physician-modified endovascular graft (PMEG) IDE, which is a treatment option for patients who are not candidates for traditional open Abdominal Aortic Aneurysm (Triple A) repair due to comorbid issues and/or their anatomy is not amenable to commercially available endografts.
The Research Coordinator, in collaboration with the Research Manager and the Department of Surgery Cardiothoracic and Vascular Surgery faculty, is responsible for providing administrative direction, coordinatimon of operations, and regulatory compliance for the PMEG IDE as well as other vascular surgery studies located primarily at HMC.
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. 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. This individual will participate in the operating room during procedures, documenting specific details and participating in the conduct of the procedure.
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 Research Coordinator 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 may work on 4-8 projects simultaneously depending on the complexity of the assignments.
OUR MISSION AND HOW THIS POSITION CONTRIBUTES The Department of Surgery is a large department within the School of Medicine, with surgeons practicing at all our locations and in eight surgical subspecialties. The UW Department of Surgery is guided by our mission of providing compassionate and high-quality patient care, training future generations of surgical leaders, and conducting research in a collegial environment which embraces diversity and promotes inclusiveness.
OUR COMMITMENT TO EQUITY, DIVERSITY, AND INCLUSION The Department of Surgery strives to dismantle systemic racism, eliminate healthcare disparities, and promote health equity in our work. Racism and intolerance have no place in our community. We celebrate our multitude of intersecting identities and commit to the ongoing effort of creating an inclusive and supportive workplace climate.
RESPONSIBILITIES Human Subjects Research Activities
Participate in the operating room during procedures, documenting specific details and participating in the conduct of the procedure.
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;
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;
Successfully submit accurate and timely UW IRB/ WCG/Advarra applications, renewals or modifications and informed consent documents.
Manage monitoring visits from sponsors.
Assist with development and monitoring of project budgets, as well as ensuring closure of budgets as needed.
Regulatory and Compliance Management
Manage all regulatory submissions (UW HSD, WCG/Advarra, device/CMS approval documents, etc.) and regulatory compliance issues.
Develop 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);
Ensure all study participant information is provided in compliance with applicable privacy regulations
Compile the annual FDA report
Bachelor's degree in health care management, biology, chemistry, microbiology, or related field
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.
Demonstrated commitment to value diversity and contribute to an inclusive working and learning environment
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
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. Candidates of non-traditional educational or experiential backgrounds are invited to apply.
Experience with IRB submissions, modification, and renewals
Certification with ACRP (CCRC) or SOCRA (CCRP)
Proficient with OnCore and Epic Hyperspace for patient enrollment, visit association and invoicing
All staff in the Department of Surgery are asked to demonstrate and develop the following core competencies. These competencies are core to success in your position.
Quality Focus: strives to deliver the best possible service and results, and continuously seeks opportunities for improvement. Key attributes: accuracy, customer service, continuous improvement, problem solving, and self-development
Planning & Organization completes work in a timely, efficient, and resourceful manner Key attributes: priority setting, efficiency, resourcefulness, adaptability and flexibility, organizational awareness, and initiative
Teamwork & Relationship Building: builds and fosters positive working relationships with others to achieve shared objectives. Key attributes: collaboration, communication, emotional intelligence, recognition, and accountability & integrity
Equity, Diversity, and Inclusion: values and honors diverse experiences and perspectives, strives to create welcoming and respectful work environments including dismantling structures of oppression, promotes and contributes to a culture of access, opportunity, and justice. Key attributes: respect, cultural humility, inclusiveness, advocacy, and commitment.
We hope you will apply and please learn more about our values and core competencies at click here.
Work could require moving between various (HMC and UWMC-ML) sites on a regular basis.
Work requires significant amount of time interacting with patients and, both on-site and in a remote capacity, e.g., phone, Zoom
Depending on the study, the work could require being in the operating room during procedures, documenting specific details of the procedure and participating in the conduct of the procedure.
Work is suitable for 1-2 days per week remote work.
Application Process: In your application, please address your own commitment to Anti-Racism. Please address applicability of education, experience, and commitment to Anti-Racism in your cover letter. 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.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.