Regulatory Specialist

1 month ago


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

Regulatory Specialist

· Dear applicant, please complete these 3 questions below with your resume. 

1.    Experience with commercial/central IRB

2.    Experience with authority logging

3.    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 - No Exemptions

 

Company DescriptionAlphaProTemps is specialized in providing "best-in-class" professional staff augmentation services. These recruiting directives include temporary labor, contract sourcing, professional & technical niches, vendor-on-site, and managed service programs.Company DescriptionAlphaProTemps is specialized in providing "best-in-class" professional staff augmentation services. These recruiting directives include temporary labor, contract sourcing, professional & technical niches, vendor-on-site, and managed service programs.

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