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The Division of Medical Oncology in the Department of Medicine has an outstanding opportunity for a full-time Research Manager.
The purpose of this position is to manage and operate the Genitourinary (GU) & Gynecological (GYN) Medical Oncology Clinical Research Program in the Division of Medical Oncology. As the Research Manager, this position reports to Faculty Director of GU Program . Functional areas include oversight of: the process of clinical trial protocol development (faculty will write the protocols), study start up, protocol implementation, data analysis, and study close out, as well as research staff supervision. Clinical research studies in the program include investigator-initiated, industry-sponsored, and NIH funded protocols.
The Research Manager will also assist with the following: implement initiatives in support of the Program’s strategic plan; identify problems with clinical trial start-up and management; assist with organized improvement efforts; and use problem solving and interpersonal skills to resolve bottlenecks.
Research Manager will also develop and maintain research procedures for the program with the goal of standardization, increased efficiency, and ensuring compliance with Institutional guidelines.
Research Manager will maintain direct communication with GU Oncology Faculty, UW departments, funding sponsors, and research collaborators in support of the overall program; and, will serve in an advisory role to research staff on research development, regulatory and compliance issues, and grants and contracts. Job performance is evaluated in terms of leadership, productivity, appropriateness and effectiveness of decision making, and overall success of the research program.
This position requires understanding the research process and ability to integrate this knowledge with research priorities to implement program goals and ensure that individual staff members and research projects support the overall mission of the entire program involving patient care and research. In addition, this position ensures that all regulatory requirements of the research projects, grants, and contracts are met. Furthermore, this position must maintain team spirit and working relationships with both internal and external partners.
The Division of Oncology is physically located in the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center campus. This position requires operational knowledge of the University of Washington, Fred Hutchinson Cancer Research Center, and Seattle Cancer Care Alliance.
The Research Manager supervises research staff and works with the program faculty and administrative staff to ensure that the Program synergizes with the overall research mission.
The vision of the Division of Oncology is to “achieve and maintain national and regional leadership in solid tumor translational research”. The Research Manager assures that the programmatic strategic plan aligns with and supports the Division of Oncology.
I. Research Development and Management (60%) II. Staff Supervision (25%) III. Financial & Regulatory Assistance (15%)
I. Research Development and Management
Implement clinical trial initiatives in support of the strategic plan surrounding overall research in Genitourinary and Gynecologic malignancies. Oversee and delegate appropriately day-to-day operations of over 40 investigator-initiated, industry-sponsored, NIH funded research studies, including:
Assist faculty with clinical trial protocol development and selection. Faculty and industry sponsors will write these protocols, but this position will provide operational insight during protocol development to streamline implementation and reduce risk for protocol deviations, as applicable. Assist Principal Investigators with management of the “menu” of trials for appropriate balance for various subsets within this disease population.
Assist the Program Operations Manager with the study start up process, by providing clinical insight on budget development, site selection and qualification processes, scientific review committee submission, IRB submission, and other relevant regulatory submissions.
Oversee clinical implementation of research protocols & work with process partners to ensure all protocol requirements are met. This includes independent management of internal start up procedures in conjunction with IDS Pharmacy, CTU Infusion, Radiology, RTS/RSPF Labs, TIMC OncoRad, RIO, and other UW & SCCA based departments. This will also include collaboration with various pharmaceutical industry sponsors, contract research organizations, and other third party vendors and laboratories.
Assisting faculty with database creation, management, and analysis for investigator initiated trials.
Overseeing study close-out process
Manage site initiation, routine monitoring, and close out visits with industry sponsors. Manage any additional site audits by FH, FDA, or study sponsors as required. In response to outcomes of these visits develop process improvements, CAPA reports, and provide retraining to staff members and faculty as applicable.
Additionally this position is expected to cover all aspects of a clinical research coordinator position in order to properly provide oversight and to be prepared for cross coverage in the event of staff changes. This would include independent management of full protocols and any associated activities with patients and data.
Develop and maintain close relationships with both internal and external partners. Develop and maintain research procedures for the Program with the goal of standardization, increased efficiency and ensuring compliance with Institutional guidelines.
II. Staff Supervision
Supervise 4-8 research staff, and administrative staff as needed.
Provide oversight and training to clinical research coordinators to ensure protocol compliance & patient safety.
Oversee the outcomes of routine monitoring visits and site inspections, and work with clinical research coordinators to implement process changes as needed.
Collaborate with Fred Hutch CRS staff to oversee CRCs in regards to clinical processes and outcomes related to patient and protocol management of NIH sponsored studies.
III. Fiscal & Regulatory Assistance
Work in collaboration with the Program Operations Manager to oversee regulatory and fiscal projects in relation to clinical research trials.
Train clinical research staff on budget guidelines and restrictions. Ensure overall fiscal compliance with current requirements per Medicare, internal budget, and UW/SCCA clinical operations. Recommend budget changes in accordance to clinical trial needs.
Collaborate with Program Operations Manager to identify and implement strategies to mitigate areas of financial risk in clinical trials budgets, both during study start up and post implementation.
Perform other duties as needed
Manage successful research clinical trials and meet all regulatory and compliance guidelines.
Assess protocol feasibility and advise program leadership.
Collaborate with internal and external partners.
Maintain direct communication with faculty members, UW departments, funding sponsors, and research collaborators in support of the overall research plan.
Help identify problems with clinical trial start-up and management. Assist with organized improvement efforts and use problem solving and interpersonal skills to resolve bottlenecks. Assist with tracking measurement statistics, and communicate results to program leadership.
Supervision of 4-8 clinical research staff, and administrative staff as necessary. Perform all aspects of supervision including hiring, training, and performance evaluation.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor's Degree in Science or health-related field plus 4 or more years experience in clinical trial management in a medical research setting or an equivalent combination of education and experience.
Thorough knowledge of IACUC, IRB, HIPAA, and FDA regulatory requirements for the conduct of research.
Experience in working within the UW/FHCRC/SCCA/CMC settings.SOCRA certification. At least one year supervisory experience.
Strong collaborative skills and leadership skills.
Excellent organizational skills and attention to detail. Knowledge of clinical trials budgeting.
Ability to prioritize competing demands to successfully meet deadlines and project milestones.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Experience in oncology clinical trials.
Familiarity with UW Grant and Contracts experience.
Familiarity and experience with: SAGE, SCC and UW clinical trial pricing processes, UW CRBB DBT for detailed clinical trials, and other UW and SCCA study start-up forms.
CONDITIONS OF EMPLOYMENT
Fast-paced office environment, with a high volume of often-complex projects. The work is deadline driven and requires rapid and frequent communications, not only between individuals, but also by computer and/or telephone for much of the day. Projects may require travel between affiliate locations to facilitate study start-up communication or grant funded projects. Work week regularly exceeds 40 hours per week.
The position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchison Cancer Research Center.
This position requires a flexible work schedule.
Stringent deadlines from sponsor organizations/companies to meet deadlines may require overtime including occasional evening and weekend overtime.
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 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.
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