What are the responsibilities and job description for the Clinical Research Regulatory Specialist position at ARIZONA ARTHRITIS & RHEUMATOLOGY ASSOCIATES?
Job Description
Job Description
Description :
The Regulatory Affairs Specialist reports to Regulatory Affairs Manager and is responsible for the items listed below.
Assists with regulatory affairs for all research sites and studies
Maintains regulatory binder by filing essential documents
IRB submissions including initial, continuing, and closeout reports
Responds to monitor requests for documents
Completes all required forms and documents through the study lifecycle
Creates, updates & maintains electronic regulatory binders and documentation for each protocol in a consistent and up-to-date manner at all times for review by sponsoring pharmaceutical company and site staff
Addresses all emails in the regulatory email inbox for action or filing
Maintains, tracks, and distributes regulatory documents for timely completion by all staff within 2 weeks
Updates Lab Certifications, logs, calibration records, and IRB rosters on file as needed
Ensures that all CV’s are updated every two years and as needed
Uploads and tracks training and credentials to personnel files
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