"Alerted.org

Kelly® Science & Clinical is seeking a **Senior Clinical Quality Assurance Specialist - Inspection Readiness.** This individual would join a leading global eye health company with a legacy spanning more than 170 years. The company is recognized for its commitment to quality, innovation, and advancing ophthalmic clinical research to deliver better outcomes for patients worldwide.

**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.

About the Role

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.

Key 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.

Regulatory/Standards Knowledge

+ ICH E6 (R3) GCP

+ ISO 14155:2020/Amend 1 (2024)

+ FDA regulations: 21 CFR 50, 54, 56, 312, 812

+ EU MDR 2017/745 and other global frameworks

Required Qualifications

+ 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 Qualifications

+ Ophthalmology clinical trial experience

+ ASQ Certified Quality Auditor (CQA) or equivalent

+ Experience with inspection readiness tools and supporting inspections across multiple regions

Why This Role

+ 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

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.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.