Clinical Quality Specialist

Kelly® Science & Clinical is seeking a Clinical Quality Specialist for our client in Rochester, New York. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Schedule : On-site Monday through Friday day shift initially

Hybrid 3 days on site – after training is complete

Length of assignment: Until the end of 2024 likely to extend into 2025

Pay: $28-29 an hour Depending on experience

Clinical Quality Specialist manages the logistics of the Global Clinical Trial Audit Program for Clinical Study Vendor audits, Clinical Site audits and Trial Master File Audits within the company s Quality Management System QMS software. This role also supports Clinical Quality Assurance activities related to ensuring Good Clinical Practices GCPs are followed during medical device and pharmaceutical clinical trials.

Responsibilities include:

• Conduct annual Vendor Risk Assessments.

• Generate and maintain annual audit schedule.

• Primary liaison with audit Consultants and Audit Firms.

• Collect Auditor qualification documentation and ensure qualifications met and required trainings completed.

• Provide audit preparation documentation working with Study Managers to identify appropriate documentation to share for the audit.

• Review/QC check audit reports and audit responses.

• Support auditees in developing effective, risk based corrective actions.

• Ensure timely delivery of audit reports and audit responses.

• Work with Procurement and Legal to finalize Master Services Agreements and Work Orders for auditing firms and consultants.

• Maintain/update the Approved Suppliers List ASL for GCP related Vendors.

• Maintain CQA SharePoint site with audit documentation

• Conduct TMF audits. Primary liaison with quality consultants.

• Facilitates all business aspects of CQA s consultant agreements.

• Maintain SOPs related to auditing in the Document Management GDMS system.

• As assigned, maintain list of relevant GCP related external standards and conduct gap assessments against current SOPs as new/updated standards become available.

• As assigned, conduct or support assessments of legacy clinical studies in support of documentation needed for EU MDR regulatory submissions.

• As assigned, conduct or support Clinical Quality Assurance continuous improvement activities.

Qualifications:

• Minimum BA/BS in related field. - Working knowledge of Good Clinical Practice regulations/guidelines ICH E6 R2 , US FDA 21 CFR 11, 50, 54, 56, 58, 312, 314, 812, 814, EU MDR 2017/745, ISO 14155:2020

• Experience working in clinical trials preferred.

• 1-2 years of experience

• Strong organizational skills and attention to detail. Excellent communications verbal and written skills and ability to work effectively in teams.

• Microsoft Teams, PowerPoint, Excel, Word, SharePoint - Experience working in Quality Management System software is a plus. - Experience working in a Document Management System like Documentum is a plus.

What happens next

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.

Helping you discover what’s next in your career is what we’re all about,

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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 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. 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.