Kelly Science, Engineering, Technology & Telecom · 5 days ago
Senior Clinical Quality Assurance Specialist
Rochester, NY
Full-time
Hybrid
Senior Level
$55/hr - $55/hr
7+ years expKelly Science & Clinical is a leading global eye health company with a legacy spanning more than 170 years. They are seeking a Senior Clinical Quality Assurance Specialist to support global clinical investigator site inspection readiness for ophthalmology studies, engaging directly with sites and ensuring compliance during regulatory inspections.
Staffing & Recruiting
No H1B
Responsibilities
Lead inspection readiness activities for global clinical sites, including pre-inspection visits, readiness reviews, interview preparation, and document workflow coaching
Support/coach site staff in key clinical quality areas: informed consent, protocol compliance, data integrity (ALCOA+), safety documentation, investigational product/device accountability, and ophthalmology-specific risks
Serve as site-facing support during regulatory inspections (FDA BIMO and others), coordinating front/back room activities, managing document requests, and ensuring accurate responses during inspections
Conduct targeted site assessments/audits based on risk and provide evidence-based readiness reports
Collaborate with cross-functional teams to strengthen site oversight, support CAPA, identify risks, and drive continuous improvement
Qualification
Required
Bachelor's degree in life sciences or related field
7–12+ years in clinical research/quality assurance (focus on investigator site-facing GCP compliance + inspection readiness)
Experience directly supporting investigator sites through live regulatory inspections; FDA BIMO experience strongly preferred
Experience with pharma trials (IND/Phase 1–4) and medical device investigations (surgical/non-surgical)
Independent, collaborative, and able to travel up to 50% (domestic/international)
Preferred
Ophthalmology clinical trial experience
ASQ Certified Quality Auditor (CQA) or equivalent
Experience with inspection readiness tools and supporting inspections across multiple regions
Benefits
Medical
Dental
Vision
Telemedicine
Term life
Whole life
Accident insurance
Critical illness
A legal plan
Short-term disability
Retirement savings plan
Service bonus
Holiday pay plans (earn up to eight paid holidays per benefit year)
Transit spending account
Paid sick leave under the applicable state or local plan
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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