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.
As a program within the Biostatistics Program in the Public Health Sciences Division of the Fred Hutchinson Cancer Research Center, the Comprehensive Center for the Advancement of Scientific Strategies (COMPASS) has been directing multi-center studies in public health research for over 30 years.
Our Mission: COMPASS promotes scientific excellence in research aimed at eliminating cancer and other diseases of public health importance by providing state-of-the-art study coordination, communication and statistical analysis services to scientific investigators.
Prepare all submissions and query responses in a timely manner to the Institutional Review Office (IRO), other external committee as appropriate (e.g. radiation safety review) to assure the protection of human subjects in research, including but not limited to: Initial Application, Modification, Continuing Review, Safety Reports, non-compliance, Confidentiality Agreement.
Prepare and maintain regulatory documents: Investigator 1572 forms, Financial Disclosure Forms, CVS, Medical licenses, Monitoring reports.
Manage the protocol activation process and track the required documents and activities needed for protocol activation. Perform review of documents for completeness and accuracy. Distribute approved documents to study team to communicate that the study/activity is approved, in a timely manner.
Ensure that IRB reporting requirements are met.
Ensure that research staff have met the standard training requirements regarding Human Subjects and GCP trainings as well as documenting completion of study specific training.
Develop and provide ongoing regulatory-related education and training for investigators and research team members. Work with study team to implement study specific training (e.g. protocol amendment training). Stay abreast of new impact or areas of knowledge and regulatory changes and disseminate this knowledge to the study staff, investigators and operations team.
Work with Fred Hutch Office of Business Develop-Strategy, as well as the collaborating organization(s) to prepare data and material transfer and use agreements (DMTUA) between international and domestic sites.
Update and manage the regulatory tracking and archive systems (e.g. SharePoint, OneDrive, OnCore). Perform periodic QA/QC to ensure that the information added is accurate and complete.
Perform internal audits and QA checks on regulatory documents.
Respond to queries with sponsors, regulatory committees, and staff in a timely manner.
Provide guidance to investigators and staff to ensure the study is being conducted as outlined in the latest institutional review board (IRB) approved protocol.
Work with manager and leadership to develop standard operating procedures (SOPs).
Coordinate and manage the regulatory documents from each participating site for studies where Fred Hutch serves as the IRB of record. For sites where Fred Hutch is not the IRB of record, track sites annual continuing reviews and alert sites to upcoming expirations to prevent lapses from occurring.
Be responsible for archiving regulatory documents/records, ensuring that all files are prepared for off-site storage in accordance with FDA, other applicable regulatory guidelines and program SOP.
BA/BS in related field required or equivalent experience.
Minimum of five years in the cancer research field.
Training in Human Subjects and Good Clinical Practice
CIP certified (certified IRB professional)
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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.