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Job Requirements of Clinical Quality Assurance (CQA) Advisor:
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Employment Type:
Contractor
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Location:
Work From Home, NJ (Remote)
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Clinical Quality Assurance (CQA) Advisor
Clinical Quality Assurance (CQA) Advisor
Location: Remote/NJ- 100% Remote
Duration: 12 Months+
Shift: 1st Shift
Pay range $40-$55/hr on w2
The Consultant, GCP Quality Assurance will assist the Head of CQA in revising the CQA Standards/SOPs, upskilling auditing practices for CQA staff, develop & deliver training (where applicable).
Tasks
- Perform gap analysis of current CQA Standards and CQA staff skill set
- Develop plan for revision of current Processes/ SOPs
- Develop roadmap for Skill set training
- Revise or create new SOPs
- Develop CQA training materials
- Deliver training
Requirements
Minimum of 5-8 years of Clinical Quality Assurance and auditing experience
Experience in SOP development
Experienced trainer
Experience with inspection management
Knowledge of ICH GCP, clinical trial methodology, and specific knowledge of applicable regulations/guidance (including 21 CFR Part 11) and ICH Guidelines related to clinical computer systems
Location: Remote