Provide Clinical Quality Assurance (GCP) Subject Matter Expertise (SME) to QED clinical study teams
Work closely with clinical study teams to ensure/coordinate appropriate documentation of quality event management, including corrective action and preventive action (CAPA) plans
Support the management, maintenance, and evaluation of QED's Quality Management System and processes for continuous improvement
Lead small-scale process improvement projects, as needed
Provide clinical quality assurance SME review of clinical protocols, and other clinical trial-related documents
Plan, conduct, and/or assist in internal and external service provider audits. Review audit reports, and any corresponding corrective and preventative actions for adequacy
Provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable
Provide support for quality metrics and performance indicators to monitor the effectiveness of clinical quality assurance activities.
Other duties as assigned or required
Requirements
Bachelor's degree in a scientific discipline or equivalent experience
Minimum of 10 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred
Knowledge of applicable GCP guidelines (e.g., CFRs and ICH)
Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
Attention to detail and proper use of tools for information processing and electronic quality management systems
Benefits
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
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