As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem solving skills and dedication to build stronger minds and a healthier world.

UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty. 

Department of Medicine: Oncology has an outstanding opportunity for a Lead Research Coordinator.

Position Purpose
The University of Washington, Division of Medical Oncology has an excellent position for a Lead Research Coordinator within the Phase 1 Program. The purpose of this position is to promote the research objectives of the Phase 1 Program in the Division of Medical Oncology (https://www.seattlecca.org/research/phase1-program). This position works with Division of Medical Oncology faculty to oversee and facilitate complex "first-in-human" Phase 1 Program investigator-initiated and pharmaceutical-sponsored clinical trials. This position will be responsible for participating in the training and hiring of new Phase I Research Coordinators and assisting with overall Research Coordinator team management. This position will also provide coverage for the Research Manager. This position will have frequent contact with Physician faculty and pharmaceutical sponsors. In collaboration with the Research Manager and physician leadership, the individual in this position will identify and implement initiatives in support of the Phase I Program's strategic plan as well as assist with organized improvement efforts.

Position Complexities
This position is constantly required to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor. This position develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Phase 1 Program. There are multiple resources available within the University system (e.g. Grant and Contract Services, Institutional Review Board, Office of Industry Relations) to help in this process, but ultimately, the work must be done independently and in a resourceful manner to expedite the Phase 1 Program's research objectives. This position is also responsible for organizing and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. Finally, this position interacts with representatives from pharmaceutical companies and health care providers in a manner that well-represents the University of Washington and its associated institution, Fred Hutchinson Cancer Center (FHCC).

The research projects managed by this position are complex. The Phase I Program, first in human, oncology trials enroll patients from multiple cancer areas who experience increased frequency of toxicity and require an extraordinary level of clinical knowledge as compared to most other oncology trials.

Position Dimensions and Impact to the University
The mission statement of the University of Washington Medical Center states that the Medical Center serves as a research resource, providing an environment in which clinical research may be conducted. This position is essential to that mission. This position provides significant contributions to research development, implementation and analysis for the Phase 1 Program in Division of Oncology.

RESPONSIBILITIES:

This position must be able to work independently on multiple research projects without benefit of written policies or procedures.  This position requires interaction with research management, principal investigators and faculty, research staff at collaborating institutions, and any other groups integral to the successful completion of research projects.

Clinical Research Development and Leadership - 35%

•Oversee and assist with supervision of the day-to-day operations of investigator-initiated and industry-initiated research studies and research coordinators.
•Assist with the staffing and workload needs and monitoring the overall workflow of the team.
•Independently train and mentor junior Research Coordinators on clinical trial management duties.
•Assist with auditing the data integrity of complex Phase I clinical trials in Florence eBinder system.
•Oversee clinical trials activity in accordance with FDA regulations, ICH GCP compliance, and institution and SOPs.
•Provide staff training and development opportunities during regularly occurring staff meetings and act as a liaison between study team and internal clinical groups.
•With the Research Manager, take part in the interviewing and hiring of new Research Coordinators.
•Serve as program representative in meetings as needed.
•Implement clinical trial initiatives in support of the strategic plan surrounding overall research in the Phase I setting.
•Assist research management with clinical trial protocol development assessing and advising PIs on protocol feasibility and staff efforts.
•Manage successful research clinical trials and meet all regulatory and compliance guidelines.
•Strategize with Phase I program management regarding trial planning, enrollment, and effort associated with trial management.
•Make recommendations on operational feasibility of new research endeavors based on collaborative review with unit partners.

Research Patient Management - 30%

•Manage complex study appointments, ordering tests and procedures to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection.
•Participate in consenting of patients with providers.
•Educate patients about the trial requirements and visit schedule.
•Conduct interviews with patients to collect research data per protocol.
•Assist in monitoring patient toxicities and interacting closely with clinical providers to ensure patient safety and protocol adherence.
•Communicate protocol requirement for treatment modifications to providers.
•Assist in communicating with external patients or external physicians who are interested in referring patients to UWMC/FHCC for Phase I Program oncology clinical trials.
•Work with internal and external physicians to screen patients and identify therapeutic pathways that optimize patient's clinical trial participation opportunities.
•Communicate with sponsors for approval to enroll patients.

Protocol Development and Management - 15%

•Develop and implement research project policies and procedures that meet research objectives and ensure compliance with all aspects of Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA).
•Design, develop, document and maintain policies and procedures for protocol registration and implementation to ensure that research execution meets good clinical practice guidelines.
•Design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives.
•Design, document and implement procedures for protocol audits to assure protocol compliance and to ensure research data quality.
•Take action to correct problems such as deviation from protocol requirements to ensure research quality.
•Work with departments outside of the Division of Oncology (e.g. Radiology) to ensure that projects are executed successfully and completed within required time frames to meet research objectives.

Analysis and Reporting - 15%

•Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion.

Other Program Support  - 5%

•Other duties and projects as assigned.

MINIMUM REQUIREMENTS:

•Bachelor's Degree in Biology or Health Science or equivalent experience
•Minimum 3 years experience in clinical, pharmacy or laboratory research project coordination

Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

ADDITIONAL REQUIREMENTS:

•Knowledge of FDA and NIH requirements relating to research involving human subjects
•Experience in clinical trial development, implementation and analysis
•Excellent written and verbal communication skills
•Experience with Microsoft Office
•Thorough knowledge of IACUC, IRB, HIPAA, and FDA regulatory requirements for the conduct of research
•Experience in working with UW/FHCRC/SCCA settings
•Strong collaborative and leadership skills.
•Excellent organizational skills and attention to detail
•Ability to prioritize competing demands to successfully meet deadlines and project milestones
•Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire.

DESIRED:

•Previous experience working with oncology patients
•Clinical research certification from one of the accredited organizations


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 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.