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 Regulatory Coordinator position will support the Immunotherapy Regulatory Aairs program and the larger Immunotherapy Clinical Research Operation team as needed. The incumbent works under the direction of the Regulatory Aairs Associate, Lead. Special skills and knowledge are applied in coordinating research and administrative activities and in carrying-out moderately complex clinical trials operations and research assignments.
Provide administrative support of regulatory documents for IRB submissions of new applications, modifications and continuing renewal reports and electronically filing of submissions and post-approvals
Manage post approval impact processes following regulatory approval to include distribution of updated study documents and training notifications
Liaise with clinical trial Investigators and immunotherapy study teams to ensure accuracy of study documentation
Administrative management of CTMS (Clinical Trial Management system) and Florence (electronic regulatory system) data entry for new studies and maintain current activity in a responsible and qualitative manner
Coordinate distribution and Investigator review of third party safety reports
Coordination of delegation of authority (DOA) log personnel signatures and tracking of training documentation across all studies as appropriate
Regulatory management of research sample acquisition studies
Support the Regulatory Aairs program in the development of process improvement activities
Perform other tasks as assigned
BA/BS in related field required, previous experience with IRB document preparation preferred, other relevant work experience may substitute
Position requires a high level of attention to detail and organization
Excellent written and verbal communication skills
Good interpersonal skills, and an ability to maintain confidentiality are essential
Must have demonstrated ability to work independently and take initiative in a dynamic environment
Working knowledge of CTMS and Florence database management preferred
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 firstname.lastname@example.org 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.