Location: Seattle, Washington
Type: Full Time
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UW’s Divisions of Cardiothoracic and Vascular Surgery, part of the UW School of Medicine’s Department of Surgery, have an exciting and mission-driven opportunity for a 1.0 FTE Research Coordinator, working with patients in various clinical research. 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, in collaboration with the Research Manager and the Department of Surgery Cardiothoracic and Vascular Surgery faculty, is responsible for providing administrative direction, coordination, operations, and regulatory compliance for industry and federal device trials, pharmaceutical trials, and registries.
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.
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.
Human Subjects Research Activities:
• 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.
• 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 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.
• Serve as liaison between the project team, industry and other stakeholders, including UWMC staff and health care providers. Keep parties apprised of study progress.
• Submit accurate and timely UW IRB/ WCG/Advarra applications, renewals or modifications and informed consent documents.
• Establish well organized, systematic, thorough research files both paper and electronic; ensure on-going file management. Implement archival process of study documents according to federal, state, and sponsor requirements
• Manage monitoring visits from sponsors.
• Assist with development and monitoring of project budgets, as well as ensuring closure of budgets as needed. As necessary, provide accurate and timely invoicing of sponsor.
Regulatory and Compliance Management
• Manage 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);
• 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
Equivalent education and/or experience may substitute for minimum requirements.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
•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
•Excellent interpersonal skills
• 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
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
All staff in the Department of Surgery are asked to demonstrate and develop the following core competencies:
• Quality Focus: strives to deliver the best possible service and results, and continuously seeks opportunities for improvement.
o Key attributes: accuracy, customer service, continuous improvement, problem solving, and self-development
• Planning & Organization: completes work in a timely, efficient, and resourceful manner
o 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.
o 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
Conditions of Employment
• 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 live 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 remote work r 1-2 days per week.
Equivalent education/experience can 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. In addition, please address your own commitment to Anti-Racism. Please address applicability of education experience, and commitment to Anti-Racism in your cover letter.
We hope you will apply and please learn more about our department, values and core complexities.
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 Workforce 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.