Clinical specialist Jobs in Rochester, NY

Job details

C linical Quality Specialist

Kelly® Science & Clinical is seeking a Clinical Quality Specialist for our client a leader in the medical device industry 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 : HYBRID- 2 days remotely - 3 days on site

Monday through Friday 8am to 5pm

Length of assignment : Until the end of 2025 possible extension into 2026

Pay : $30-35 an hour

Support the Clinical Quality Assurance function within Research and Development Operations with responsibility for managing audit program including audit schedules, audit records and CAPAs in the Quality Management Software, and conducting TMF audits ensuring clinical trials supporting pharmaceutical and medical device registrations are conducted incompliance with all applicable regulations.

Primary Responsibilities include

Establishes, updates, and maintains annual audit schedule for GCP Vendors in the Quality Management Software (QMS). Collects, reviews, and stores audit deliverables such as audit reports, audit response requests, CAPAs, and relevant audit support documentation in QMS.

Maintains the GCP Vendor Approved Supplier List (ASL).

Primary liaison with quality consultant auditors and auditing vendors. Coordinates auditors for clinical site, GCP vendor, and Trial Master File (TMF) audits.

Liases with internal functional team members in Clinical Operations, Data Management, Statistics, Trial Master File, Clinical Trial Material, Clinical Development, and Clinical Quality Assurance to ensure preparation documentation is identified prior to audit.

Ensures new auditors complete and pass the qualification activities and stores evidence of qualification in Clinical Quality Assurance (CQA) SharePoint site.

Tracks audit deliverable timelines and ensures timely submission of audit documentation in accordance with Standards Operating Procedures. Communicates and escalates risk audit timelines.

Prepare folders in SharePoint for auditors with audit preparation documentation.

Develops and tracks vendor performance metrics to identify trends and mitigate emerging quality issues.

Conducts TMF audits, once qualified.

Contributes to or writes standard operating procedures.

Performs gap assessments on current SOPs against emerging standards, regulations, and guidelines

Requirements

Minimum BS / BA in related field.

Working knowledge of Good Clinical Practice (GCP) regulations / guidelines (ICH E6 (R2) and (R3)); MDR 2017 / 745, ISO 14155 : 2020 (and 2024), FDA 21 CFR 50, 54, 56, 58, 312, 314, 812, 814, 820), and other applicable regulations, guidelines and standards for clinical research.

STRONG organizational skills required.

Strong in Microsoft Word, Excel, and PowerPoint.

Strong Microsoft TEAMS experience preferred.

Strong attention to detail.

Able to follow written and verbal directions and ultimately become independent in managing audit program.

Excellent communication required.

Experience with working with individuals from other countries / cultures a plus.

Ability to problem solve with critical thinking to troubleshoot issues.

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,

9743601