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.
The Director of Clinical Trial Coordination provides leadership and oversight to oncology clinical trial management activities across the Fred Hutch, University of Washington, and Seattle Children’s Cancer Consortium (“Cancer Consortium”). The position is responsible for directing the work of 4+ clinical research teams that support the Phase I Program trial portfolio and disease-based program portfolios that include phase I-IV therapeutic, multi-site industry trials, investigator-initiated trials, and national cooperative group trials. As a key leader in the Cancer Consortium’s central clinical trials office, Clinical Research Support (CRS), the Director is responsible for driving strategic initiatives, fostering collaboration, and ensuring operational success across multiple research programs. The position reports to the Vice President of Clinical Research and works in close collaboration with the Clinical Research Program Medical Director.
Please apply to this role at:
https://careers-fhcrc.icims.com/jobs/29938/director%2c-clinical-trial-coordination/job
Responsibilities
In partnership with the Program Medical Director, formulate and implement operational strategies for oncology clinical research programs that align with individual program goals and organizational priorities.
Oversee study management activities ensuring efficient trial activation and conduct in compliance with applicable regulations, guidelines, institutional policies, and standard operating procedures (SOPs).
Direct program resource planning and management based on trial portfolio, direction and growth; partner with finance team to ensure adherence to budgets and adjust resourcing plans accordingly.
Identify opportunities to improve efficiency, and enhance the overall quality of clinical trial operations, recommend solutions, and lead changes that may include team structure, processes improvements, or adoption of technology solutions.
Work in close partnership with other central teams including protocol development, study startup, regulatory affairs, and compliance to ensure integrated, compliant, and efficient end-to-end trial management.
Define and report-out program metrics and key performance indicators for institutional and Cancer Consortium leadership, and faculty.
Qualifications
MINIMUM QUALIFICATIONS:
Bachelor's degree or equivalent qualification or experience
Minimum three years of staff management experience and five years of experience in all phases of clinical trial/protocol management
Ability to identify and resolve complex clinical trial issues
Demonstrated knowledge of clinical trial design, operations, and regulatory requirements
Working understanding of applicable regulations and guidelines including FDA, ICH GCP, and HHS
Strong leadership, organizational, and multitasking skills are essential
PREFERRED QUALIFICATIONS:
Advanced degree preferred
Clinical research-related certification preferred
Experience overseeing study teams in an academic research institution preferred
Deep understanding of therapeutic oncology clinical trial operations and phase I trial requirements preferred
Experience working in Epic preferred
Experience working with clinical trial software including an electronic regulatory binder system, electronic data capture systems (EDCs), and a Clinical Trial Management System (CTMS) preferred
The annual base salary range for this position is from $161,450 to $269,048, and pay offered will be based on experience and qualifications. This position may be eligible for relocation assistance. This position may be eligible for sign on bonus.