Careers

Description:

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.

The Department of Medicine: Oncology has an outstanding opportunity for a Clinical Trial Assistant to join their team.

Position Purpose

This position is responsible for clinical trial start-up and implementation coordination and reporting development in the Thoracic, Head & Neck (THN) and Neuro-Oncology Clinical Research Program in the Division of Medical Oncology. This position will accelerate clinical trial study start-up and amended clinical trial protocols by developing forecast tools, study intake, and coordinating study documents and submissions to internal and external stakeholders with minimal supervision. This position will ensure adherence to start-up processes and procedures among various UW, SCCA and Fred Hutch departments, including the UW Clinical Trial Office, FHCC Clinical Operations Research Services, Fred Hutch Clinical Research Support and Clinical Trial Management System.

Position Complexities

Medical Oncology is a Division within the Department of Medicine. The Division’s primary mission is to improve cancer care by moving discoveries made in the laboratory to a clinical setting and finding new and innovative ways to use existing therapies. Our vision is to be national leaders in oncology translational medicine.

The Division of Medical Oncology is primarily located in the Seattle Cancer Care Alliance (SCCA) / Fred Hutchinson Cancer Center campus, but also has faculty and staff located at University of Washington (UW) Medical Center, Harborview Medical Center, the VA Puget Sound Health Care System, and South Lake Union. This position interacts closely with multiple process partners, including SCCA/FHCC and UW clinical and administrative departments, and multiple regulatory committees.

In collaboration with the Clinical Trial Specialist and Clinical Research Implementation Manager, this position will maintain dynamic communication with the study investigators, research staff, numerous University departments, SCCA/FHCC departments, and other development partners (other universities, federal, and industry partners). There are multiple resources available within the University system to help in this process, but ultimately, the work must be done with limited assistance and in a resourceful manner to expedite opening a clinical trial and maintaining trial related resources. This position interacts with representatives from pharmaceutical companies, health care providers and colleagues in a manner that well-represents the University of Washington.

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 is key to the success of the THN and Neuro-Oncology Clinical Research Program as timely study start-up and accurate study source maintenance is of direct benefit to those we serve. This position will require a strong partnership with faculty and staff within and external to the programs.


DUTIES AND RESPONSIBILITIES

This position must be able to work independently on multiple research projects with minimal written policies or procedures.  This position requires daily interaction with pharmaceutical sponsors, physicians, THN and Neuro-Oncology team members, and other partners. Up to 10 study start-up projects and 40 active trials will be in progress simultaneously, with the expectation of additional projects in the future.

Clinical trial start-up and implementation (75%)

• Establish meetings between external research partners and the THN and Neuro-Oncology program.
• Manage Confidentiality Disclosure Agreements (CDAs), Feasibility Questionnaires, submissions per OSP requirements.
• Arrange Pre-Selection Visits (PSV) and disease group review meetings.
• Work independently to collection and manage study materials and pre-approvals.
• Oversee CTMS, REDCap and UW OSP submissions and document control.
• Prepare and submit eGC1s in accordance with OSP requirements and deadlines.
• Ensure Significant Financial Interest (SFI) disclosure compliance is completed and required approvals are received by OSP deadlines.
• Forecast, track and report study start-up timelines.
• Assist THOR and Neuro-Onc Managers with developing start-up tools and metrics.
• Produce monthly and quarterly study start-up metric reports using established formats.
  
  Pre-Award Fiscal (25%)
• Establish and maintain methods to initiate study start-up budget and pricing planning.
• With minimal guidance, coordinate and communicate with UW and SCCA/FHCC offices involved in the review and negotiation of clinical trial budgets and contracts, including UW Clinical Research Budget and Billing office, the UW Office of Sponsored Programs, and the SCCA/FHCC clinical research systems.
• Working with THOR and Neuro-Onc Managers and faculty, establish methods to translate study start-up pricing and budget efforts into study tracking tools, to streamline the invoicing of sponsors based on patient accrual and visits.
  
  Perform other duties as assigned.
  
  
  MINIMUM REQUIREMENTS
   
• Bachelor’s Degree in Science-related field.
• Minimum one year with clinical research budget development, clinical research coordination, clinical administration, or related research or healthcare experience.
  
  Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
  
  
  ADDITIONAL REQUIREMENTS
   
• Ability to work effectively and efficiently in a group environment.
• Exceptional organizational and customer service skills.
• Strong written and oral presentation skills.
• Ability to communicate effectively with all levels of faculty, management and clinical research staff.
• Thorough knowledge and ability to convey complex policy.
• Ability to teach and mentor others in group settings, in one-on-one sessions, and remotely.
• Ability to prioritize and organize work independently.
• Demonstrated skill in using Microsoft Excel.
  
  
  DESIRED QUALIFICATIONS
   
• Experience in an academic medical center
• Experience as a research study coordinator
• Experience in oncology clinical research
• Experienced in clinical administration
• Knowledge of project management
• Experience with REDCap, Clinical Trial Management System (CTMS), UW systems
• Strong working knowledge of Microsoft Office Suite