Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The Clinical Research Support Director of Clinical Operations is responsible for direct oversight of programs that support start-up, scientific review, and NCI data reporting for Cancer Consortium clinical research. The incumbent leads the relevant operational design and oversight of the Clinical Trial Management System (CTMS). The incumbent defines and report metrics to study teams and Consortium administration working towards system improvements within the incumbents team, as well as throughout the Consortium.
The incumbent manages multi-disciplinary teams. They will attract, develop, and retain strong teams; contribute to short and long-term organizational planning and strategy as a member of the management team to strategize growth and resource utilization. The position reports directly to the Director of CRS.
Oversee central study startup program:
Manage, oversee, and scale trial startup portfolio to ensure coordinated study reviews, budget and contract negotiations, and compliant source documentation within the Consortium
Work across CRS teams and other partner organization functions needed to support study startup
Gather and report study startup metrics and status on a regular basis
Identify study startup process issues and resource needs across the Consortium; propose and implement solutions
Create tools to manage the study startup process
Represent Consortium start-up processes and central support to leadership, faculty, study teams, and external organizations
Lead efforts to improve start-up processes across the Consortium
Direct the startup protocol review and data reporting functions:
Oversee committee management for the Scientific Review Committees (SRC); ensure that the Consortium meets NCIs requirements for the SRC including start-up, trial prioritization and trial accrual rates.
Propose and manage Consortium policies to ensure the Consortium meets SRC and data reporting requirements
Serve as Consortium and Fred Hutch institutional lead on the CTMS workflow development:
Provide support and leadership to CTMS implementation and management
Ensure CTMS operations are in alignment with the business needs of the Consortium
Represent Clinical Research Support services to study teams, faculty, leadership, and peer institutions
Identify gaps in Consortium research support; implement new programs and services to address operational gaps
Represent CRS at Cancer Consortium meetings, committees and performance improvement initiatives
Identify, champion, and implement process improvement opportunities to Fred Hutch and Consortium executive leadership, by providing sufficient context, data, as well as recommended solutions and resources.
Experience and Abilities
5-10 years starting and managing clinical trials operations, preferably oncology
Managing multi-disciplinary teams
Communicating with all levels of a research organization
Working across different academic institutions to facilitate research projects
Working with multi-disciplinary teams
Forecasting and meeting deadlines
Coaching study teams
Strong understanding of NCI mandates for data reporting and infrastructure
Using judgment and effective decision making skills with competing interests and priorities
Knowledge and Skills
Masters degree healthcare related field preferred
Clinical research related certification preferred
Familiarity with process improvement principles
Familiarity with project management tools and techniques
Strong verbal and written communication skills
Knowledge of the regulatory environment surrounding clinical trials
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.