Regulatory Specialist

Regulatory Specialist

Description:

Required Qualifications:
• Bachelor’s degree
• 3+ years in the field of clinic research
• Writing research correspondence to IRB and study sponsors.
• Submitting continuations and amendments to regulatory bodies.
• Tracking regulatory documents (including lab certifications, CV’s, IRB compliance and correspondence letters, medical licenses, FDA Forms, Delegation of Authority Forms, Serious Adverse Event submissions, etc.)
• FDA Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) as well as Local Institutional Review Board (IRB) regulatory requirements.
Preferred Qualifications:
• 1+ years oncology experience
• CCRP certification

COVID-19 Vaccine (Facility Guideline): Required - No Exemptions

Flu Vaccine (Facility Guideline): Unknown

FDA and Regulatory and oncology and (IRB or GLP or GCP or CCRP)