Clinical Research Quality Assurance Consultant

October 10

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ProTrials Research Inc.

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CRO management services • Clinical Monitoring • Clinical Project Management • Clinical Site Management • Clinical Study Start-up

51 - 200

Description

• We opened our doors with a clear and simple vision: to provide the worldwide clinical research industry with professional services that demonstrate the highest level of experience, quality, and integrity. • Since 1996, ProTrials has supported research that has led to ground-breaking treatments and solutions in the pharmaceutical, biotechnology, and medical device industries. • Most of us entered the clinical research field to help patients, caregivers, or maybe even our loved ones. • We show up every day committed to do work that matters. • When you join ProTrials, you will join a collaborative community helping to build a healthier world. • We also understand your need to balance a meaningful workload with life’s every-day moments. • At ProTrials, we know that this makes our employees happier, healthier, and more successful. • The Clinical Quality Assurance Consultant will provide consultation in the interpretation of good clinical practice (GCP) regulations, guidelines, policies, and procedures. • The Clinical QA Consultant will plan, conduct, and report on independent audits of internal systems/ procedures and vendors. • The QA Consultant supports, maintains, and reviews QA systems, corporate training programs, and corrective action and preventative actions (CAPAs).

Requirements

• Strong knowledge of FDA, GCP, and ICH regulations, guidelines, and standards governing regulated clinical research required • Working knowledge and understanding of drug development and global clinical regulatory environment • Insightful, decisive, proactive, and solutions-oriented • Proven excellence in professional skills including communication, organization, prioritization, discretion, and accuracy • Exceptional customer service skills, including cultivating and maintaining close working relationships with both internal and external stakeholders • Proficiency in MS Office including Word, Excel, PowerPoint, Outlook, SharePoint, OneNote, and virtual meeting software • Flexibility with shifting priorities • Available to travel as needed