Regulatory Specialist
1 month ago
**Job Location**: 1919 Santa Monica Blvd. Suite 400 Santa Monica, CA 90404**Description**:Location: 1919 Santa Monica Blvd. **Experience with commercial/central IRB** Experience with authority logging **Managing research studies for multiple sites**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**
**Job Type**: Contract
Pay: $40.00 - $54.00 per hour
**Benefits**:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Application Question(s):
- Total years of Experience with commercial/central IRB
- Total years of Experience with authority logging
- 3+ years in the field of clinic research
**Experience**:
- FDA regulations: 1 year (preferred)
Work Location: On the road
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