Univ - Regulatory Post-activation Coordinator - Hollings Cancer Center

Medical University of South Carolina

Charleston, SC, US
Base: $45,300.00 - $77,000.00 annually; bonus/equi...
Hybrid
Irb submission preparation and tracking
Oncore system proficiency required
Good clinical practice guidelines knowledge
The Medical University of South Carolina is seeking a Regulatory Post-Activation Coordinator for its Hollings Cancer Center in Charleston, SC. This role involves managing regulatory submissions, document management, and coordinating sponsor monitor visits, with the potential for a hybrid work schedule after an orientation period

Job Summary

  • The Regulatory Post-Activation Coordinator supports day-to-day regulatory submissions, renewals, and changes from study activation until termination.
  • This role ensures compliance with Good Clinical Practice Guidelines by managing document quality assurance and preparing for external sponsor or FDA audits.
  • Employees may be eligible for a remote or hybrid work schedule following the completion of an orientation period.

Matching Summary

Match Score: 85

The Medical University of South Carolina is seeking a Regulatory Post-Activation Coordinator for its Hollings Cancer Center in Charleston, SC. This role involves managing regulatory submissions, document management, and coordinating sponsor monitor visits, with the potential for a hybrid work schedule after an orientation period.

Salary

Base: $45,300.00 - $77,000.00 annually; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • IRB submission preparation and tracking
  • OnCore system proficiency required
  • Good Clinical Practice Guidelines knowledge
  • Monitor visit scheduling and coordination
  • Trial master file maintenance

Nice-to-have

  • Process improvement project participation
  • Mentorship and training capabilities
  • Effective cross-functional communication
  • Adaptability to hybrid work schedules

Key Requirements

  • Bachelor's degree required
  • Two years of relevant program experience
  • Proficiency with OnCore and eReg systems

Work Rights

Not specified

Tailored Resume

Cover Letter