Careers in Food and Drug Law

CLINICAL START-UP SPECIALIST
University of Washington
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CLINICAL START-UP SPECIALIST

University of Washington

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Details
Posted:
March 19, 2020
Location:
Seattle, Washington
Salary:
Open
Type:
Full Time

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. All of which has allowed the UW to be nationally recognized as a “Great College to Work For” for six consecutive years. 

The Division of Medical Oncology in the Department of Medicine has an outstanding opportunity for a Clinical Start-Up Specialist.

This position is responsible for clinical trial study start up in the Thoracic, Head & Neck Oncology (THOR) program in the Division of Medical Oncology. This position will accelerate clinical trial study start up by developing and optimizing new and ongoing study start-up processes. This position works with minimal supervision and negotiates optimal pricing and payment terms with sponsors; coordinating the submission of a wide range of study start-up documents including pricing requests to various UW, SCCA, and FHCRC departments, developing study budgets, negotiating study budgets. This position requires the ability to understand clinical research coordination, revenue cycle development, budgeting, compliance, and regulations.

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), on the Fred Hutchinson Cancer Research 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, UW, and FHCRC clinical and administrative departments, and multiple regulatory committees.

The research projects managed by this position are complex. This position requires the ability 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 is required to use independent judgment and knowledge of the academic clinical trial business to effectively facilitate the workflow and promote a collaborative work environment.

The position will maintain dynamic communication with the study investigators, research staff, University departments, SCCA departments, and the FHCRC departments, other development 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. This position interacts with representatives from pharmaceutical companies, health care providers and colleagues in a manner that well-represents the University of Washington.

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 THOR Clinical Research Program as timely study start-up 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.

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, THOR team members,  and other partners. Up to 8 projects will be in progress simultaneously, with the expectation of additional projects in the future.

Manage clinical trial start-up processes

  • Establish and maintain methods to initiate study start-up budget planning.
  • Use knowledge of clinical research, medical terminology, and clinical processes to translate complex oncology protocol requirements into clinical trial budgets and facilitate submissions to relevant compliance offices.
  • Working with THOR 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.
  • Forecast, track and report study start-up timelines.
  • Prepare and submit eGC1s in accordance with OSP requirements and deadlines
  • Ensure SFI compliance is completed and required approvals are received by OSP deadlines
  • Independently negotiate successful clinical trial budgets and payment terms with study sponsors.
  • Coordinate and communicate with UW and SCCA 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 Seattle Cancer Care Alliance Research Implementation Office
  • Assist THOR Managers with developing start-up tools and metrics
  • Develop and track study start-up pieces and report progress to THOR Managers, faculty, and study team members.
  • Produce monthly and quarterly study start-up metric reports using established formats.

    Protocol Implementation

  • Independently develop and implement research project procedures and tools that meet research objectives and ensure compliance with all aspects of Institution, 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). Communicate research requirements effectively with all providers involved in patient care.
  • Design, develop, document and maintain policies and procedures for protocol 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 satisfies research objectives. Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality. Develop and implement corrective action plans to ensure protocol adherence and data integrity.

    Perform other duties as assigned.

    As a UW employee, you will enjoy generous benefits and work/life programs.  For detailed information on Benefits for this position, click here.

    REQUIREMENTS:

  • Bachelor's degree in business, science or health-related field plus a minimum of two years experience with budget development, clinical research coordination, or related project management or health care experience

    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
  • Ability to convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience
  • 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 Office Suite
    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.

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

    DESIRED

  • Experience in an academic medical center
  • Experience as a research study coordinator
  • Experience in oncology clinical research
  • Familiarity with interpreting regulatory and contractual documents, identifying and resolving ambiguities, negotiating pricing and payment terms, and interpreting complex implications of research protocols.
  • Knowledge of the Medicare Clinical Trials Policy and other federal, state and institutional clinical research regulation
  • Strong working knowledge Microsoft Office Suite.
  • Experience with the Study Review and Management Portal (sRAMP)

    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 budgeting communication. 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. Travel to/from campus buildings is required. Position requires the ability to lift study binders and materials as needed as they may be stored away from immediate desk.
  • 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.
    		•

    Internal Number: 177996
    About University of Washington
    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 undergraduate 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.
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