Regulatory Associate I
Core
Conduct regulatory activities for oncology clinical trials, preparing submissions and documentation to ensure compliance with institutional, state, and federal guidelines.
Role type
Regulatory Associate I (Clinical Research)
Builds
Regulatory submissions and documentation for multi-institutional, industry-initiated, and NCI clinical research studies
Domain
Healthcare / Clinical Research / Oncology
Required skills
Regulatory affairs, Clinical research, FDA guidelines, NCI guidelines, GCP, HIPAA compliance, Clinical trial documentation, Data entry, Trial activation management, Audit preparation
Preferred skills
SoCRA, ACRP, RAPS, CIP certification
Technologies
Clinical Trials Management System (CTMS)
Responsibilities
Create and coordinate regulatory submissions for oncology trials; Revise informed consent documents and HIPAA forms; Organize study regulatory files; Enter trial data into CTMS; Participate in study activation and site visits; Communicate trial status to investigators and sponsors; Compile regulatory metrics for management.
Seniority
Mid-level, hands-on IC
