REALTIME

eRegulatory Management Maintain study regulatory files within

REALTIME.

Upload, organize, and manage regulatory documentation. Coordinate electronic signature routing and approval workflows. Maintain document version control. Assist sites with regulatory filing and document management activities. Support implementation of regulatory workflows within

REALTIME.

Assist with user training related to

REALTIME

eRegulatory functions. Regulatory Maintenance Maintain regulatory documentation throughout the study lifecycle. Track expiration dates for investigator licenses, CVs, GCP training, laboratory certifications, financial disclosures, and other essential documents. Coordinate collection and filing of updated regulatory documentation. Maintain delegation logs, training records, study-specific regulatory files, and essential documents. Ensure regulatory files remain inspection-ready throughout study conduct. Sponsor and Site Support Serve as a regulatory resource for research sites. Respond to regulatory questions from site personnel. Support sponsor portal document uploads and maintenance. Assist with sponsor, CRO, and IRB communications. Coordinate regulatory documentation requests. Support onboarding of new research sites and study teams. Study Close-Out and Archiving Conduct regulatory close-out reviews. Verify completeness of essential documents prior to archival. Ensure all required regulatory documentation has been collected and filed. Coordinate document retention and archiving activities. Training, SOPs, and Process Improvement Support implementation and maintenance of CVRS regulatory SOPs. Participate in regulatory training initiatives. Assist with standardization of regulatory processes across the network. Support CAPA and quality improvement activities as assigned. Contribute to development of regulatory tools, templates, and best practices. Qualifications Education Associate's Degree required. Bachelor's Degree in Life Sciences, Healthcare Administration, Public Health, or related field preferred. Experience Minimum 2 years of clinical research regulatory experience required. Experience preparing IRB submissions, amendments, and continuing reviews required. Experience supporting study start-up and site activation activities preferred. Experience working in a multi-study or multi-site environment preferred. Preferred Qualifications Experience using

REALTIME

CTMS and eRegulatory modules strongly preferred. Experience with central IRBs and local IRBs. Experience supporting sponsor and CRO interactions. Experience preparing studies for sponsor monitoring visits, audits, and inspections. Experience supporting remote research operations. Knowledge, Skills, and Abilities Strong knowledge of ICH-GCP guidelines. Working knowledge of FDA regulations and human subject protection requirements. Exceptional attention to detail and document accuracy. Strong organizational and project management skills. Ability to manage multiple studies and competing deadlines. Excellent written and verbal communication skills. Ability to work independently in a remote environment. Proficiency with Microsoft Office applications and electronic regulatory systems. 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Clinical Research Regulatory Coordinator (Brandon, Florida)