Clinical Research Operations Specialist

Job ID
21584
Type
Regular Full-Time
Location
US-WA-Seattle
Category
Clinical Research Support Services

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

 

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 facilitate and manage study startup for oncology clinical trials in the Cancer Consortium. The incumbent will be responsible for assessing the operational logistics, financial and implementation requirements and managing startup timelines of new industry-sponsored clinical trials. This position will work closely with internal and external regulatory and fiscal specialists to manage startup 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 centralized study startup standard practices, budget negotiation and clinic implementation in support of larger CRS strategic goals initiatives. This position requires understanding of project and timeline management, understanding of the research process, operationalizing industry-sponsored clinical trial protocols, and knowledge of financial resources required to conduct clinical research.

Responsibilities

  • Project manage the study startup timeline and operations (including budget development, negotiations and clinic implementation) in continuity with centralized study startup teams standards and practices in support of larger consortium and department 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 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., review of startup timelines goals, dependencies, milestones and comprehensive integration of protocol requirements for study implementation).
  • Maintain source documentation, correspondence and startup records throughout the startup process (i.e. from study kickoff to study handoff) in alignment with centralized study startup standard practices.
  • Monitor and maintain standard internal trackers, timelines and logs to maximize transparency and efficiency among central startup members.
  • Work closely with Startup Operations Manager, CRS Startup Team members, consortium members and study teams to support comprehensive study startup process, goals and deadlines.
  • Work proactively with central offices, clinic partners, faculty members and research collaborators to ensure protocol requirements can be met upon study activation.
  • Report startup progress to industry sponsors, investigators and study teams weekly to ensure transparency throughout the startup process.

Qualifications

  • Bachelor’s Degree
  • 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
  • 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
  • Knowledge of Outlook, MS Teams, Microsoft Office

**Please submit a cover letter when completing the application for this position**

 

In addition to job duties at Fred Hutch, this position also requires access to Seattle Cancer Care Alliance, which requires COVID-19 vaccination without exceptions.
Accordingly, as a condition of employment for this Fred Hutch position, newly hired employees must provide proof of vaccination before their first day of employment. 

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your 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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