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.
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.
The Clinical Research Operations Specialist will provide and manage support for clinical trial start-up in the Cancer Consortium. The incumbent will be responsible for assessing the operational logistics of new industry-sponsored clinical trials and creating start-up plans including review requirements and timelines. This position will work closely with internal and external regulatory and fiscal specialists to manage start-up tasks including the preparation of industry-sponsored clinical trial budgets and will work closely with study teams, central offices, clinic partners, faculty members and research collaborators to ensure implementation needs are met. This position will facilitate and support centralized study start-up standard practices, budget negotiation and clinic implementation in support of larger CRS strategic goals initiatives. This position requires understanding of the research process for industry-sponsored clinical trials, knowledge of start-up requirements, clinic implementation, and financial resources required to conduct clinical research.
Project manage the study start-up timeline and operations (including budget development, negotiations and clinic implementation) in continuity centralized study start-up best practices with the goal of standardization and efficiency in support of larger CRS strategic initiatives
Review and assess new clinical trial documents to identify operational and resource requirements
Identify research costs, develop comprehensive budgets and maximize negotiation of industry sponsored clinical trials that support protocol implementation and institutional requirements (i.e. institutional fees, procedure and administrative costs, study team time and effort, etc.)
Prepare, submit, and manage internal financial and clinic implementation processes on behalf of the study team
Initiate and facilitate meetings with industry sponsors and study teams (i.e., development and review of projected start-up timelines, milestones and comprehensive integration of protocol requirements for study implementation)
Maintain source documentation and records throughout the start-up process for continuity with internal file structure, naming conventions, start-up best practices and transparency at the time of study hand-off
Monitor and maintain centralized internal logs and trackers to maximize transparency and efficiency among CRS Start-Up Team members
Work closely with Start-Up Operations Manager, CRS Start-Up Team members, Consortium members and study teams to support comprehensive study start-up plan, goals and deadlines
Work proactively with central offices, clinic partners, faculty members and research collaborators to ensure all protocol requirements can be met upon implementation
Report start-up progress to industry sponsors, Investigators and study teams weekly to ensure transparency throughout the start-up process
Generate financial tools that enable study teams to maximize post award management and cost recovery
Develop tools to assist study teams with start-up process
Preparing and/or reviewing study startup documents
Working across different academic institutions to facilitate research projects
Working with multi-disciplinary teams
Forecasting and meeting deadlines
Communicating with all levels of a research organization
Knowledge and Skills
Bachelors Degree required
Clinical research related certification preferred
Familiarity with project management tools and techniques
Strong verbal and written communication skills
Knowledge of applicable local, state and federal regulations and guidelines
Basic knowledge of clinical trial budgets
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through 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 [email protected] or by calling 206-667-4700.
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.