Research Regulatory Coordinator - 155101

Description

Prepare, manage, and track regulatory submissions for oncology clinical trials.

Maintain essential documents and ensure every study meets the highest ethical, safety, and compliance standards.

Collaborate closely with investigators, sponsors, and multidisciplinary oncology teams to keep trials moving forward.

Serve as a trusted resource for regulatory guidance across early-phase, late-phase, and disease-specific cancer studies.

Requirements

• Minimum 2 years of regulatory experience in oncology or complex therapeutic area clinical research
• Deep working knowledge of FDA, OHRP, ICH GCP, and institutional regulatory requirements
• Proven success preparing and submitting IND safety reports, protocol amendments, continuing reviews, and IRB submissions
• Familiarity with central IRBs, local IRBs, and multi site regulatory coordination
• Demonstrated ability to manage multiple studies simultaneously in a fast moving research environment
• Strong proficiency with clinical trial management systems (CTMS), eReg systems, and electronic IRB platforms
• Exceptional communication skills with investigators, sponsors, monitors, and cross-functional oncology teams
• Ability to interpret complex regulatory guidance and provide clear, proactive recommendations to study teams