Regulatory Affairs Specialist-cc

University of Pennsylvania

Philadelphia, Pennsylvania, US
Base: $62,000.00 - $70,119.00 annual rate; bonus/e...
Fully remote
Irb and fda regulatory documentation processing
Knowledge of ich gcp guidelines
Experience with human research protection regulations
The position involves coordinating Phase I-V clinical trials for the Abramson Cancer Center at the University of Pennsylvania

Job Summary

  • The position involves coordinating Phase I-V clinical trials for the Abramson Cancer Center at the University of Pennsylvania.
  • Candidates will prepare and process all regulatory documentation through the IRB, CTSRMC, FDA, and other applicable review committees.
  • The university offers a competitive benefits package including excellent healthcare, tuition benefits, and generous retirement plans.

Matching Summary

The position involves coordinating Phase I-V clinical trials for the Abramson Cancer Center at the University of Pennsylvania.

Salary

Base: $62,000.00 - $70,119.00 Annual Rate; Bonus/Equity: Not specified; Benefits: Comprehensive medical, dental, vision, life insurance, tuition assistance, retirement plans

Skills & Requirements

Must-have

  • IRB and FDA regulatory documentation processing
  • Knowledge of ICH GCP guidelines
  • Experience with human research protection regulations
  • Strong organizational and time management skills
  • Effective problem solving and critical thinking abilities

Nice-to-have

  • Experience in oncology regulatory research
  • Willingness to work in a fast-paced environment
  • Openness to constructive criticism and learning
  • Ability to resolve regulatory and data queries
  • Self-driven with heightened attention to detail

Key Requirements

  • Bachelor's degree in life science or human subject protection field
  • 3-5 years research experience required
  • At least 1 year regulatory experience preferred
  • Intermediate/expert level Microsoft Office proficiency
  • Associated research credentialing (CCRP, CIP) preferred

Work Rights

Not specified

Tailored Resume

Cover Letter