Sr. Regulatory Coordinator

Fred Hutchinson Cancer Center•Seattle, WA

13d•Hybrid

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.

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

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