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Elite Clinical Network · 6 hours ago

Regulatory Coordinator

Chandler, AZ

Full-time

Onsite

New Grad, Entry Level

Elite Clinical Network is seeking a Regulatory Coordinator to play a key role in ensuring clinical trial compliance. This role involves preparing, submitting, and maintaining all regulatory documents required for study initiation and conduct, while supporting adherence to FDA, IRB, and GCP regulations.

Consumer SoftwareHealth CareMarket ResearchPharmaceutical

Responsibilities

Prepare, submit, and maintain all essential regulatory documents (e.g., Form 1572, CVs, medical licenses, financial disclosures, IRB submissions, etc.) for clinical trials

Coordinate initial and continuing review submissions, protocol amendments, and safety reports to the Institutional Review Board (IRB)

Maintain regulatory binders and trial master files to ensure completeness, accuracy, and compliance with sponsor and regulatory requirements

Track submission deadlines, approval expirations, and other critical regulatory timelines

Communicate with sponsors, CROs, and study monitors regarding regulatory documentation and site readiness

Assist in the preparation for sponsor audits and regulatory inspections

Collaborate with clinical and administrative staff to ensure all site and investigator documentation is current and compliant

Support the initiation, monitoring, and closeout of studies by ensuring regulatory documentation is accurate and up to date

Qualification

FDA regulationsICH-GCP guidelinesIRB processesMicrosoft Office SuiteElectronic regulatory systemsRegulatory submissionsClinical research processesSponsor auditsFDA inspectionsCCRP certificationOrganizational skillsCommunication skillsAttention to detail