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)

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