Regulatory Affairs Coordinator

2 weeks ago


Santa Monica, California, United States A.P.R., Inc. (AlphaProTemps) Full time
Job Overview

Regulatory Affairs Coordinator

We invite qualified candidates to address the following inquiries along with their application materials:

1. Proficiency with commercial or central Institutional Review Boards (IRB)

2. Experience in authority documentation

3. Oversight of research projects across multiple locations

Essential Qualifications:

Bachelor's degree

• Minimum of 3 years in clinical research

• Proficient in drafting research communications to IRB and study sponsors.

• Responsible for submitting continuations and amendments to regulatory authorities.

• Management of regulatory documentation (including laboratory certifications, CVs, IRB compliance correspondence, medical licenses, FDA Forms, Delegation of Authority Forms, Serious Adverse Event submissions, etc.)

• Knowledge of FDA Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), as well as Local Institutional Review Board (IRB) regulatory standards.

Desirable Qualifications:

• At least 1 year of oncology experience

CCRP certification

COVID-19 Vaccination Requirement: Required - No Exemptions

Company Overview

A.P.R., Inc. (AlphaProTemps) specializes in delivering top-tier professional staffing solutions. Our recruitment services encompass temporary staffing, contract sourcing, professional and technical specialties, vendor-on-site services, and managed service programs.



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