Clinical Research Operations Specialist

Job ID
18105
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Clinical Research Support Services

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.


At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

 



The Clinical Research Operations Specialist will provide and manage support for clinical trial start-up in the Cancer Consortium. The incumbent will be responsible for assessing the operational logistics of new industry-sponsored clinical trials and creating start-up plans including review requirements and timelines. This position will work closely with internal and external regulatory and fiscal specialists to manage start-up tasks including the preparation of industry-sponsored clinical trial budgets and will work closely with study teams, central offices, clinic partners, faculty members and research collaborators to ensure implementation needs are met. This position will facilitate and support centralized study start-up standard practices, budget negotiation and clinic implementation in support of larger CRS strategic goals initiatives. This position requires understanding of the research process for industry-sponsored clinical trials, knowledge of start-up requirements, clinic implementation, and financial resources required to conduct clinical research.

Responsibilities

  • Project manage the study start-up timeline and operations (including budget development, negotiations and clinic implementation) in continuity centralized study start-up best practices with the goal of standardization and efficiency in support of larger CRS strategic initiatives
  • Review and assess new clinical trial documents to identify operational and resource requirements
  • Identify research costs, develop comprehensive budgets and maximize negotiation of industry sponsored clinical trials that support protocol implementation and institutional requirements (i.e. institutional fees, procedure and administrative costs, study team time and effort, etc.)
  • Prepare, submit, and manage internal financial and clinic implementation processes on behalf of the study team
  • Initiate and facilitate meetings with industry sponsors and study teams (i.e., development and review of projected start-up timelines, milestones and comprehensive integration of protocol requirements for study implementation)
  • Maintain source documentation and records throughout the start-up process for continuity with internal file structure, naming conventions, start-up best practices and transparency at the time of study hand-off
  • Monitor and maintain centralized internal logs and trackers to maximize transparency and efficiency among CRS Start-Up Team members
  • Work closely with Start-Up Operations Manager, CRS Start-Up Team members, Consortium members and study teams to support comprehensive study start-up plan, goals and deadlines
  • Work proactively with central offices, clinic partners, faculty members and research collaborators to ensure all protocol requirements can be met upon implementation
  • Report start-up progress to industry sponsors, Investigators and study teams weekly to ensure transparency throughout the start-up process
  • Generate financial tools that enable study teams to maximize post award management and cost recovery
  • Develop tools to assist study teams with start-up process

Qualifications

Experience and Abilities

  • Minimum 2-3 years’ experience coordinating industry-sponsored clinical trials, preferably oncology trials
  • Preparing and/or reviewing study startup documents
  • Working across different academic institutions to facilitate research projects
  • Working with multi-disciplinary teams
  • Forecasting and meeting deadlines
  • Communicating with all levels of a research organization


Knowledge and Skills

  • Bachelor’s Degree required
  • Clinical research related certification preferred
  • Familiarity with project management tools and techniques
  • Strong verbal and written communication skills
  • Knowledge of applicable local, state and federal regulations and guidelines
  • Basic knowledge of clinical trial budgets

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, 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 hrops@fredhutch.org or by calling 206-667-4700.

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