Quality Associate

Job overview

The Quality Associate role is onsite in Bellaire, TX. Compensation is not specified. The position reports to the VP of Compliance and supports quality and regulatory oversight of clinical research trials. The associate audits trial activities and records, communicates findings, and maintains regulatory documentation. The role helps ensure research is conducted and reported in accordance with protocols, standard operating procedures, good clinical practice, and applicable regulations.

What you'll do

• Perform quality control checks and audits of clinical trial documents and activities
• assist with QA and QC reports
• communicate findings and evaluate responses
• maintain QA records and study files
• identify process improvements and quality trends
• interpret applicable regulations
• prepare and submit regulatory documents to IRBs, sponsors, and agencies
• maintain regulatory binders and archives
• prepare for monitoring visits and audits
• and coordinate multiple study projects as needed.

What we're looking for

Skills & competencies

quality associate

bellaire tx

pinnacle clinical research

clinical research

quality assurance

clinical trial audits

gcp

regulatory compliance

irb submissions

study documentation

citi training

compensation not specified

Work arrangement

• Weekend coverage required

Benefits & perks

• 401(k), medical, dental, vision, disability, HSA, and life insurance
• three weeks of paid time off
• 14 paid company holidays
• and a scrub voucher for applicable positions.

Why this role

The role includes travel between two New Jersey sites, as stated in the posting, and requires CITI and GCP training certification.

About the employer

Pinnacle Clinical Research is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.