Salary is commensurate with experience and education
The University of Washington (UW) is proud to be one of the nation's premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty.
The University of Washington's Division of Medical Oncology includes 41 faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Research Center, the Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System. Over the past 25 years, members of the Division have developed the world's leading bone marrow transplant program. In addition, members of the Division have made substantial contributions to many other areas of cancer treatment, including the use of tumor vaccines, cellular therapy for cancer, antibody-based treatments, and novel forms of chemotherapy and hormonal therapy. Our Division is deeply committed to maintaining its position as one of the leading centers for research and treatment of cancer in the world.
The Division of Oncology has an outstanding opportunity for a full-time Clinical Research Manager. The purpose of this position is to manage and operate the Gastrointestinal (GI) Medical Oncology Clinical Research Program in the Division of Medical Oncology. As the Research Manager, this position reports to the Faculty Director of the GI 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 both investigator-initiated and industry-initiated 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.
The 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.
The Research Manager will maintain direct communication with GI 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 II. Financial Management III. Staff Supervision
I. Research Development and Research Management Implement clinical trial initiatives in support of the strategic plan surrounding overall research in the Gastrointestinal malignancies. Respond to key funding opportunities that match specific project proposals or that further programmatic goals. Oversee and delegate appropriately day-to-day operations of investigator-initiated and industry-initiated research studies, including:
Assisting faculty with clinical trial protocol development (faculty will write protocols, but there will need to be management of the menu of trials for appropriate balance)
Perform the study start up process, including budget development and negotiations, scientific review committee submission, IRB submission, and other relevant regulatory submissions.
Overseeing implementation of research protocols, work with process partners to ensure all protocol requirements are met
Overseeing and assisting faculty with data analysis
Overseeing study close-out process
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. Fiscal Management
Communicate budget guidelines and restrictions to research staff to ensure overall fiscal compliance. Oversee research billing by research staff is in accordance with current budget and UW procedures. Recommend budget changes in accordance to clinical trial needs. Collaborate with Program Operations Specialist to identify and implement strategies to mitigate areas of financial risk.
III. Staff Supervision
Supervise 4-8 research staff, and administrative staff as needed. Perform all aspects of supervision including hiring, training, and performance evaluation.
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.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
BS in Science and/or equivalent clinical research experience, including clinical research professional certification.
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. ACRP 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.
Experience in oncology clinical trials.
UW Grant and Contracts experience.
Prior 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.
Condition of Employment:
Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check.
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, Criminal Conviction History, 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 undergra...duate 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.