• Research Administrator III- Clinical Trial Budgets

    Job ID
    14328
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Administrative Support
  • Overview

    Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


    The Research Administrator III proactively provides compliant and effective pre-award funding support by developing and negotiating study budgets as part of clinical trial start-up for multiple Principal Investigators and their labs/departments. This position works closely with regulatory, clinical research and data coordinators as well as institution sponsored research and site of practice personnel to ensure timely and effective study implementation completion.


    The position collaborates with Principal Investigators and interfaces with other departments as needed to provide research administration and to contribute to strategic planning as it relates to their study portfolio. The Research Administrator III works in an autonomous manner to complete clinical trial pre-award content and tasks, and to advise PIs on relevant matters. This position will report to one of the Clinical Research Program Operations Directors within the Clinical Research Division.

    Responsibilities

    Budget/Fiscal Support

    • Support strategic planning activities of the PI such as providing trial-specific fiscal information
    • Develop, monitor, track and project complex multi variable budgets
    • Develop, run and analyze reports to identify issues and escalate as needed
    • Develop custom report formats to share information with the team/department
    • Partner with finance to resolve identified budget and expense issues
    • Identify and discern discrepancies with expenses and escalate as needed

     

    Funding Source Administration

    • Lead the study implementation process by conducting key tasks such as creation and communication of timelines to appropriate stakeholders, completion of nontechnical and assigned technical/non-scientific portions of submission, and oversight of institutional signoff
    • Perform key pre-award activities such as flagging unique aspects or budget adjustments, negotiating trial-specific budgets with industry partners, addressing critical budget components to ensure adequate funding including recommending when a study should not move forward due to inadequate funding support.

    Regulatory Support – as needed

    • In consultation with PI(s) study teams, prepare non-scientific portions of study implementation submissions
    • Manage timelines and ensure completion of all necessary trial-specific pre-award documentation in a timely manner
    • Identify necessary trial start-up implementation components of submissions, confirm that required items are in place, resolve issues (escalating as appropriate)
    • Determine impact of and develop implementation plans in response to applicable staff changes, protocol amendments and/or revisions to Center policies and procedures
    • May serve as a central point of contact to answer questions, escalating issues as needed

     

    Administrative Support

    • Communicate key administrative tasks to colleagues as needed such as timeline for scheduling study SIV, communicating RG code and funding activation and identifying unique aspects for post-award management
    • Identify administrative issues for discussion with leadership
    • Assist with the development of lower level staff
    • May coach and develop lower level staff
    • May manage projects including feasibility budgeting for investigator-initiated trials

     

    Leadership

    • May act as a divisional resource and assist with training for lower level staff

     

    Clinical Trials Addendum

    • Create, negotiate, and finalize budget based on protocol (Core)
    • Partner with external organizations to get pricing
    • Facilitate Clinical Trials Agreements (CTAs) and review and escalate CTA language as needed
    • Ensure all financial documents are in place (CT)
    • Tracking and Auditing of procedures to ensure compliance (CT)
    • Set up and maintain study document tracking systems (CT)
    • Amend budgets as needed by colleagues through the life of a study (Core)
    • Attend study implementation meetings as needed (CT)
    • Manage multi-site components as needed (sub awards) (Core)

    Qualifications

    Required

    • High school diploma or equivalent required. Associates or bachelor's degree preferred
    • Three years of relevant experience. Four years or relevant experience and two years of experience as a research administrator preferably with principal investigators/academics preferred
    • Advanced proficiency with Microsoft Office/Adobe
    • Working knowledge of Excel formulas and functions such as creating formulas and working with Pivot Tables
    • Knowledge/prior experience with Enterprise Software Systems
    • Ability to source data from systems and generate customized reports
    • Efficiently planning, organizing, and prioritizing your work as well as that of others
    • Ability to tailor communications to specific audiences
    • Ability to navigate complex internal systems and departments
    • Basic budgetary knowledge (ability to reconcile, manage, report budget information, etc.)
    • Basic knowledge of accounting terminology
    • Knowledge of relevant regulatory guidelines such as IRB
    • Prior experience or exposure to funding mechanisms within a clinical and research environment

     

    Preferred

    • Knowledge of clinical and scientific terminology
    • Experience within a clinical research setting
    • Knowledge of and experience with FDA regulations
    • Experience with Contract Research Organizations
    • Prior supervisory experience
    • Certified Research Administrator

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.

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