Manager, Clinical Research Operations

Job ID
23156
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 for 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.   

 

We are actively expanding our central team to support Principal Investigators (PIs) and research study teams who are focused on mission-critical clinical trials programs.  

 

The Manager, Clinical Research Operations is primarily responsible for setting vision and executing scalable & sustainable research management practices for designated research programs in our oncology clinical trials portfolio. The trial portfolios include multi-site investigator-initiated IND trials, industry trials, and single-site investigator-initiated trials. 

Responsibilities

  • Set vision and strategy for building and managing research teams that can effectively deliver on research program goals.  
  • For designated research programs:
    • Assess protocol feasibility and advise program leadership and PIs on clinical trial protocol development and selection
    • Oversee the study startup process partnering closely with the central startup team
    • Oversee implementation of research protocols through the entire life cycle of a study from feasibility assessment to closeout
    • Oversee protocol related activities of designated research staff including clinical research coordinators, data coordinators, reg coordinators, research team nurses
    • Develop and maintain close relationships with internal and external partners
    • Develop and maintain standard operating procedures (SOPs) for each program, aiming for standardization wherever possible across programs
    • Understand total costs and effort related to each study and actively manage study budget through the lifecycle of a study
  • Define administrative direction and implementation of research management functions, best practices, policies and SOPs to meet the needs of multiple disease groups/research programs. 
  • Foster collaboration and clear engagement models between research management functions, CRC functions, data coordination functions, research nursing functions and clinic operations functions.   
  • Form and execute plan to staff growing team by developing staff and offering professional growth opportunities. 
  • Compile and evaluate research resource utilization and allocation. 
  • Make recommendations to leadership and oversee changes in operations as necessary. Develop systems for continuous monitoring. 
  • Define and report-out program metrics and key performance indicators for UW and FH department/division, institutional and Consortium leadership, and faculty. 

Qualifications

MINIMUM QUALIFICATIONS:

  • Bachelor's degree/equivalent qualification or experience 
  • 3 years’ experience of coordinator experience in the conduct of interventional, treatment, and/or FDA-regulated clinical trials, preferably oncology trials 
  • At least 2 years professional experience managing teams. Strong leadership skills are required to lead clinical resources through periods of growth, change and time pressure. The ideal candidate will have a demonstrated ability to:
    • Manage a diverse team, think creatively and globally, project future needs, and be attuned to the day-to-day division operations 
    • Effectively lead individual teams as well as act collaboratively across an organization 
  • Knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations 
  • Excellent interpersonal skills with the ability to build strong relationships with a diverse group of stakeholders 
  • Experience working with EHR systems 
  • Experience working with clinical trial management system 
  • Excellent leadership abilities 
  • Excellent computer skills including ability to use wide variety of software packages for research data management 
  • Excellent oral and written communication skills 

 

PREFERRED QUALIFICATIONS:

  • Demonstrated track record of hiring, training, and mentoring a team of clinical research coordinators 
  • Clinical research-related certification preferred 
     

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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