Regulatory Coordinator I/II - Lab Based Studies

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

Qualifications

• Regulatory Coordinator I: 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.
• Regulatory Coordinator II: 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.