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 Monitoring Operations Manager will be responsible for providing oversight of the administrative operations of the internal clinical research monitoring program. The incumbent will work under the direction of the CRS Regulatory Affairs and Compliance Assistant Director who manages the Monitoring Program.
Manages daily administrative and operational activities related to the monitoring and auditing of clinical research studies
Schedules monitoring activities in accordance with the Institutional Data and Safety Monitoring Plan
Develops Standard Operating Procedures (SOPs), materials, and tools which may include monitoring documents, study management/data collection instruments, and educational materials.
Guides the development of project and departmental procedures
May attend monitoring wrap-up meetings
Develops, reviews, edits, and revises tools used by the monitoring group
Provides ongoing guidance and assistance to study teams
Manages Clinical Research Resources Website (CRRW) SharePoint site
Produces special and recurring reports used by CRS management
Hires, trains, and supervises internal staff and contract clinical research monitors (CRAs) in conjunction with the Regulatory Affairs and Compliance Assistant Director.
Experience and Abilities
5+ years working in a clinical research setting
Working with multi-disciplinary teams
Communicating with all levels of a research organization
Development of SOPs
Knowledge and Skills
ACRP or SOCRA certification
Supervisory experience required
Familiarity with process improvement principles
Strong written and verbal communication skills
Excellent organizational skills and attention to detail
Proficiency in Word, SharePoint, Excel, Acrobat, OneDrive
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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.