Regulatory Coordinator I/II - Lab Based Studies

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 http://www.fredhutch.org.