Clinical Research Operations Manager - Sarcoma

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. 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 value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism 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. Reporting to the Assistant Director of Clinical Trials Coordination, the role will oversee a clinical research team within Medical Oncology which includes Breast Oncology, Genitourinary Medical Oncology, Gastrointestinal Oncology, Sarcoma and other specialized Oncology Programs.

 

Responsibilities

• Set vision and strategy for building and managing research teams that can effectively deliver on research program goal
• For designated research programs:
  • 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
• Develop staffing plans, address professional growth opportunities, and support team development
• 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
• Other duties as assigned.

Qualifications

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor's degree/equivalent qualification or experience 
• 4 years’ experience in the conduct of interventional, treatment, and/or FDA-regulated clinical trials, preferably oncology trials 
• At least 2 years’ experience directly or indirectly managing personnel and training team members
• 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 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 

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or