Regulatory Specialist
1 month ago
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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