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 Hutch's 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 nation's first cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.The Regulatory Operations Manager will be responsible for overseeing the day-to-day regulatory management of intervention oncology clinical trials, including: investigator-initiated trials, NCI National Clinical Trial Network (NCTN) trials (cooperative group clinical trials) and industry-sponsored trials., as well as Institution-Sponsored, Investigator-Initiated Trials. The position will manage all aspects of study start-up, modification submissions, continuous reporting, and study close-out to the Institutional Review Board (IRB) and any relevant regulatory agencies including, the Institutional Biosafety Committee, the institutional Radiation Safety Committee, and the pharmaceutical sponsor, funding foundation, or governmental agency. In addition, this position will have knowledge of and represent these research programs in regulatory affairs requirements mandated by Cancer Consortium partner institutions: Fred Hutchinson Cancer Research Center, the University of Washington and the Seattle Cancer Care Alliance. The Regulatory Operations Manager is responsible for managing other regulatory coordinators and regulatory assistants. The position will report directly to the Clinical Research Support (CRS) Quality and Compliance Manager.Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize growth.Represent CRS Quality and Compliance as a regulatory consultant at process improvement workgroups, institutional meetings, and conferencesProvide regulatory support to NCI NCTN program and Institution-Sponsored IND (ISI) Program and oversee maintence of all required regulatory documents. Provide regulatory start-up support for the central Study Start-up Team including industry-sponsored and investigator-initiated trials.Partner with Consortium study teams to provide ad hoc regulatory management for ongoing clinical trials.Oversee, coordinate, and prepare regulatory study start-up documents and maintenance of protocol submissions to internal and external governing bodies. These include but are not limited to the Cancer Consortium IRB, NCI Central IRB, the Institutional Biosafety Committee, Radiation Safety Committee, and Scientific Review Committee.Oversees timely regulatory submissions to meet institutional, NCI NCTN and other relevant project timelines.Create and maintain Standard Operating Procedures (SOPs) and ensures program compliance with the SOPs.Identify program improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to Consortium study teams.Coordinates with Regulatory Affairs team as needed to address regulatory-related quality and compliance matters.Assists with the development of standard training requirements and assists with ongoing regulatory-related education and training for. investigators and research personnel Perform internal audits and quality assurance reviews on regulatory files, as neededWrite and edit clinical research trial consent forms in accordance with FDA regulations and guidances and GCP guidelines.Liaise with investigators, study teams, sponsors, and Institutional Review Office (IRO) representatives on all clinical trial regulatory operations.Required Experience and Abilities:Experience coordinating clinical research, preferably oncology trials.Minimum of 5 years of regulatory experience in the conduct of interventional, treatment, and/or FDA regulated clinical trials, preferably oncology trials.Knowledge of NCI cooperative group clinical trials.Experience as a lead or senior coordinator; supervisory experience preferred.Knowledge and Skills:Bachelor's Degree required.Master's degree in a healthcare related field preferred.Clinical research related certification required.Knowledge of NCI cooperative group trial structure.Advanced knowledge of FDA regulations, GCP guidelines and other applicable federal regulations.Strong verbal and written communication skills.Ability to work on multiple projects and delegate tasks effectively.Project Management experience preferred.Strong time management skills.Excellent interpersonal skills with the ability to build strong relationships across multiple organizations.Advanced knowledge of electronic IRB submission systems and/or clinical trial management systems (CTMS).Advanced knowledge of standard office software packages (Word, Excel, PowerPoint, Project, Acrobat, Visio, etc.).
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.