Job Description
Fred Hutchinson Cancer Center is an independent, nonprofit organization focused on cancer treatment and research. The Regulatory Coordinator ensures compliance for investigator-initiated and lab-based studies by coordinating regulatory submissions and assisting with compliance monitoring. Responsibilities Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA and other institutional and federal oversight committees, including drafting and reviewing content as appropriate Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional and federal regulations Assures the proper management, retention, and version control of all applicable regulatory documentation including study regulatory binders and files With input from PI(s), draft research protocol documents and clinical research informed consent forms Coordinate activities to ensure they follow timelines and meet deadlines Lead study start-up: prepare and submit all required regulatory documents for new study applications; successfully open new studies from inception to accrual May prepare and present materials for monitoring visits and serve as primary point of contact during visits Independently follow-up and resolve issues related to regulatory concerns identified during regulatory review and monitoring visits Prepare and submit modifications/amendments and continuing renewals for ongoing study maintenance Conduct study close-out Process IND external safety reports; maintain documentation of PI review and submit/escalate safety reports as appropriate Report non-compliance and unanticipated problems to IRB as applicable Serve as liaison for internal regulatory bodies (IRB, IBC, IACUC, Regulatory Affairs, etc.) Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team Uses judgment to interpret and apply federal and local regulations regarding research May perform internal audit and quality assurance checks on regulatory documents May serve as primary regulatory resource for physicians, sponsors and study team, providing guidance on regulatory statuses, approvals and instructions regarding research participant consent Identify, develop and implement any necessary revisions to related policies and procedures Skills High school diploma or equivalent Minimum of one year of regulatory, human research protection, or related experience in a research environment Demonstrated knowledge of regulatory guidelines (IRB, IACUC, MUA, etc.) Knowledge of FDA, GCP and NIH requirements In addition to minimum qualifications for Regulatory Coordinator I, at least two years of regulatory, human research protection or related experience in a research environment Ability to interpret and synthesize regulations and guidelines Ability to adapt and adjust priorities based on changing needs, strong written and verbal communication skills, problem solving skills and the ability to reach and reconcile data in reports Ability to use discretion and maintain confidentiality Proficiency with MS Office suite Associate or Bachelor's degree Two to three years of work experience in clinical research with emphasis on IRBs, Ethics Committee and Human Subjects review in pharmaceutical, biotechnology, or academic research settings Experience with regulatory affairs in an academic research environment Clinical Research Coordinator certification (CCRC) or Research Professionals certification (ACRP or SOCRA) Prior experience working with NIH, FDA and OHRP regulations 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) Company Overview Fred Hutch is an independent, nonprofit organization that also serves as the cancer program for UW Medicine. It was founded in 1975, and is headquartered in Seattle, WA, US, with a workforce of 1001-5000 employees. Its website is