Senior Clinical Quality Assurance Specialist

Title: Senior Clinical Quality Assurance Specialist – Inspection Readiness (Contractor)

Pay: Starting at $55/hour (higher rates considered for exceptional alignment)

FT or PT:>
Full-time, 12-month contract (potential to extend or convert)

Location: Remote (U.S.

-based) |
Travel: Up to ~50%, Domestic travel, as needed.

As a Senior Clinical Quality Assurance Specialist – Inspection Readiness, you will play an essential, hands‑on role supporting global clinical investigator site inspection readiness for ophthalmology studies across pharmaceuticals and surgical/non‑surgical medical devices. You’ll engage directly with investigator sites, coaching staff and study teams, assessing and closing readiness gaps, and providing support onsite or remotely during regulatory inspections. This position is remote but requires travel up to 50% during peak inspection periods.

• 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.

• ICH E6 (R3) GCP
• ISO 14155:2020/Amend 1 (2024)
• FDA regulations: 21 CFR 50, 54, , 312, 812
• EU MDR 2017/745 and other global frameworks

• 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)

• Ophthalmology clinical trial experience
• ASQ Certified Quality Auditor (CQA) or equivalent
• Experience with inspection readiness tools and supporting inspections across multiple regions

• Directly influence inspection outcomes, site quality, and patient/data protection
• Autonomy + collaboration within global clinical programs
• High‑impact role shaping the future of ophthalmology clinical research

Ready to advance your career? Apply today to join our client’s expert‑driven team and help drive innovation in clinical trial quality and inspection readiness.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce.

Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E‑Verify and will provide the federal government with your Form I‑9 information to confirm that you are authorized to work in the U.S.