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 employeeswho bringdifferent and innovativeways of seeing the world and solving problems.Fred Hutch is in pursuit of becoming an antiracist organization.Weare committed to ensuring that all candidates hired share our commitment to diversity,antiracism, and inclusion.
The Senior Regulatory Coordinator position is part of the central regulatory team within the Fred Hutch and UW/Fred Hutch Cancer Consortiums clinical trials office, Clinical Research Support (CRS). The team supports a large portfolio of clinical trials in oncology and infectious disease, including COVID-19 trials, and manages the institutions electronic regulatory binder (eReg) system. The Senior Regulatory Coordinator is responsible for preparing and maintaining FDA and IRB documents, and other study-related tools for the start-up and management of clinical trials. The position will also support the teams management of eReg, including the system workflows, SOPs, and training documentation.
Prepares and submits regulatory documents to the IRB to request initial, yearly, and protocol amendment approvals for Phase I-III clinical trials, including: industry sponsored, investigator initiated, institution sponsored IND clinical trials
Prepares and submits regulatory documents to the FDA to obtain initial protocol and amendment approvals for industry sponsored and institution-sponsored IND trials
Assists with creation and maintenance of eReg processes and documentation; serves as Subject Matter Expert (SME) to end-users
Writes local consent forms from industry templates as well as from investigator-initiated protocols
Establishes and maintains trial regulatory files
Facilitates SAE processing to comply with IRB and FDA reporting requirements for IND trials
Prepares data for scheduled and ad hoc reports for ongoing review of safety data, and IND annual reports
Bachelors degree required
Three years regulatory experience or clinical trials and/or prevention study management experience
Clinical research related certification preferred
Experience working in electronic regulatory binder system preferred
Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)
Experience reviewing IRB documentation and research protocols
Experience writing technical documents
Ability to work collaboratively and build relationships across a large organization
Excellent written and verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing
Excellent time management skills
Advanced knowledge of MS Word and Acrobat
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism 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 HR Operations at HRops@fredhutch.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.