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Sr. Regulatory Coordinator
About the position
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington. With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality. At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. The department of Clinical Research Support (CRS) is the central clinical trials office for the University of Washington/Fred Hutch Cancer Consortium. The Sr. Regulatory Coordinator is responsible for preparing documentation for industry sponsored, investigator initiated, and national cooperative group clinical trials. This position will support our Phase I Oncology portfolio and is a hybrid position requiring two days on site weekly.
Responsibilities
- Serves as a central point of contact internally and externally for Phase 1 trials
- Facilitates meetings and collaboration with key stakeholders
- Prepares and submits regulatory documents to the IRB including initial application, annual renewal, and modifications for industry sponsored, investigator initiated, and national cooperative group clinical trials
- Establishes and maintains Cancer Consortium and Sponsor regulatory files
- Creates and maintains study-related tools and templates for the start-up and regulatory management of clinical trials
- Prepares local consent forms from industry templates as well as for investigator initiated protocols; provides formatting and editing assistance for investigated initiated trial documents
- Facilitates SAE processing to comply with FDA reporting requirements for IND trials
- Liaises with investigators and study teams to ensure accuracy of documentation
- Extracts data from Institutional databases to report study accrual data
- Extracts data from study data bases for scheduled and ad hoc reports for ongoing review of safety data and IND annual reports
Requirements
- Bachelor’s Degree in biological, social or physical science or equivalent years of expereince.
- 2 years of regulatory, clinical trials and/or prevention study management experience
- Previous experience with protocol design and review
Nice-to-haves
- Master’s degree
- Experience writing technical documents
- Clinical research related certification
- Ability to communicate clearly, succinctly and effectively over the phone and in writing
- Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH)
- Experience reviewing IRB documentation and research protocols
- Ability to work collaboratively and build relationships across a large organization
- Excellent time management skills
- Advanced knowledge of MS Word and Acrobat
- Excellent written and verbal communication skills
- Effective organizational skills
Benefits
- medical/vision
- dental
- flexible spending accounts
- life
- disability
- retirement
- family life support
- employee assistance program
- onsite health clinic
- tuition reimbursement
- paid vacation (12-22 days per year)
- paid sick leave (12-25 days per year)
- paid holidays (13 days per year)
- paid parental leave (up to 4 weeks)
