CLINICAL QUALITY SPECIALIST - Kelly Services : Job Details

Job detailsClinical Quality SpecialistKelly® 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 initiallyHybrid 3 days on site - after training is completeLength of assignment: Until the end of 2024 likely to extend into 2025Pay: $28-29 an hour Depending on experienceClinical 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 nextOnce 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,#19547394