Research - Laboratory/Non-Laboratory, Staff/Administrative
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The University of Washington, Division of Medical Oncology has an excellent position for a Clinical Research Manager in the Breast Cancer Research Program (BCRP).
The purpose of this position is to manage and operate the BCRP in the Division of Medical Oncology. This position reports to the Faculty Director of the Breast Cancer Program and functional areas include oversight of: clinical trial protocol development, study start up (including budget development/negotiations and regulatory submissions), data analysis and study close out, as well as research staff supervision. Clinical research studies in the BCRP include both investigator-initiated and industry-initiated protocols.
Assist in implementing initiatives in support of the Program strategic 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.
Develop and maintain research procedures for the Program with the goal of standardization, increased efficiency and ensuring compliance with Institutional guidelines.
This position will maintain direct communication with Breast Cancer Faculty, UW departments, funding sponsors, and research collaborators in support of the overall BCRP; 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 BCRP 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 Program vision. 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 Program needs synergize 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.
Duties & Responsibilities:
I. Research Development and Management (60%) II. Financial Management (25%) III. Staff Supervision (15%)
I. Research Development and Research Management
Implement clinical trial initiatives in support of the Program strategic plan. 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.
Perform and oversee the study start up process, including budget development and negotiations, scientific review committee submission, IRB submission, and other relevant regulatory submissions. Work with process partners to ensure all regulatory requirements are met.
Overseeing and assisting faculty with data analysis.
Perform and oversee study close-out process.
Forecast, track and report study start-up timelines.
Oversee regulatory affairs to ensure BCRP clinical trials meet regulatory requirements and are compliant with federal and institutional policies.
Compose, review, edit and implement BCRP regulatory policies and procedures. Develop process improvements via policy and procedure development and training programs.
This position will work to create and maintain program Standard Operating Procedures (SOPs), as well as ensure program compliance with the SOPs. This position may also perform Quality Assurance checks on regulatory files as needed.
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 to ensure practices are in accordance with current budget and UW procedures. Recommend budget changes in accordance to clinical trial needs. Collaborate with program Grant and Fiscal Manager to identify and implement strategies to mitigate areas of financial risk.
III. Staff Supervision
Supervise research staff including Research Coordinators, Data Coordinators, Regulatory Coordinators and Research Assistants.
Manage clinical trial operations, all regulatory and compliance guidelines. Assess protocol feasibility and advise Program leadership and PIs.
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 clinical research staff. Perform all aspects of supervision including hiring, training, corrective actions 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 of experience in clinical trial management in an oncology medical research setting to include 1 year of supervisory experience.
Thorough knowledge of IRB, HIPAA and FDA regulatory requirements for the conduct of research.
Experience in working within the UW/FHCRC/SCCA settings..
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.
CONDITIONS OF EMPLOYMENT
This position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center campus. Travel to/from campus buildings is required. Work hours frequently exceed 40 hours per week and can be deadline dependent.
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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