IIT Program Operations Director

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. 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. 

We are actively expanding our Clinical Research Support (CRS) team to support Principal Investigators (PIs) and research study teams who are focused on mission-critical clinical trial programs. The Investigator-Initiated Trial (IIT) Program Operations Director is primarily responsible for strategy and operational management of protocol development, project management and data management for IITs in our oncology clinical trials portfolio.  The IIT trial portfolios include multi-site investigator-initiated IND trials, and single-site investigator-initiated trials. 

The incumbent manages the lifecycle of IITs from Letters of Intent (LOI), feasibility, protocol writing, database design, coordinates financial and operational startup, amendments, to data analysis and publication. The incumbent will develop systems for managing each aspect of this lifecycle and drive progress with investigators, research teams and various stakeholders engaged in IITs from initiation to publication.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Responsibilities

PRIMARY/ESSENTIAL DUTIES:

• Responsible for establishing an integrated IIT Program Office that provides protocol development, data management, startup & amendment related processes for IITs from initiation to closeout.
• Directly oversee a team comprising Protocol Writers, Project Managers, and EDC Design Leads, and project-manage the work of various specialists engaged in study startup (Regulatory, Financial, Clinic, Lab, etc.); remain accountable for projects end-to-end.
• Responsible for ensuring study protocol and other required minimum documentation are complete, vetted with all relevant stakeholders, and aligned prior to study entering startup.
  • Oversee protocol writers and actively manage or coordinate with staff who are engaged in development of protocol and ancillary documents (manuals, patient facing documents) through an iterative development process until final signoff by Investigator.
  • Facilitate financial, clinic feasibility completion and alignment with protocol documents prior to studies entering startup.
  • Establish and implement requirements and expectations for stakeholder inputs and reviews, including biostatistics, Community Outreach and Engagement, and applicable internal resources such as manufacturing and specialty labs.
  • Engage central Regulatory Affairs Specialists when an IND submission is required and ensure project plan accounts for FDA timelines.
  • Manage timelines related to each activity and manage PI expectations and deliverables.
• Oversee the development and maintenance of guidelines, Standard Operating Procedures (SOPs), workflows, and templates to support related to protocol development and data capture & management activities for IITs.
  • Maintain protocol templates for treatment trials, interventional non-treatment trials, and non-interventional studies; ensuring appropriate stakeholder review and communications prior to release.
  • Oversee authoring and maintaining of data-related documents including, but not limited to: eCRFs, eCRF Completion Guidelines, and Data Management Plans.
• Identify and implement systems to support efficient and quality IIT protocol and database development and management.
  • Stay current on electroni