Consultant, GxP Services

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Advarra

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1983

💼 Consulting

📦 Logistics

📣 Marketing

Consulting • Logistics • Marketing

Advarra is a provider of integrated technology and services for clinical research, combining institutional review and compliance services with software platforms to support the full clinical trial lifecycle. The company offers ethics review services (IRB, IBC, DMC, endpoint adjudication), site enablement and research staffing, and a suite of cloud products — including eRegulatory, eConsent, eSource/EDC, CTMS and study design tools — plus an AI-powered operational intelligence engine (Braid) to streamline trial start-up, enrollment, and operations. Advarra serves sponsors, CROs, research sites, and institutions with a focus on patient protection, regulatory compliance, and accelerating trial outcomes.

📋 Description

• Support consultants in delivering GxP consulting services for pharmaceutical, biotechnology, medical device, and life sciences clients • Assist with planning and conducting domestic audits and assessments under senior team direction • Plan and perform independent audits with SME support • Support inspection readiness activities as a co-auditor • Participate in mock inspections with senior consultants • Assist with SOP reviews and documentation • Support client communications with the project team • Participate in continuous improvement initiatives and consulting engagements • Participate in investigator site, TMF, vendor, facility, document, and systems audits • Prepare audit documentation, reports, observations, and supporting project deliverables • Assist with quality control reviews of project documentation and data • Support compliance assessments, SOP reviews, gap analyses, and quality system improvement initiatives • Assist with developing client training materials and participate in GxP-related training delivery • Collaborate with project managers and senior consultants to meet timelines and client expectations • Maintain current knowledge of applicable GxP regulations and industry best practices • Support internal process improvement initiatives and perform other assigned duties

🎯 Requirements

• Bachelor's degree in Nursing, Life Sciences, or related field, or equivalent combination of education and experience • Minimum 3-5 years of experience in clinical research, quality assurance, regulatory compliance, or related life sciences environment • Ability to travel extensively, with travel required up to 50%-70% • 1-3 years of experience supporting GxP, QA, compliance, auditing, or operational functions • Experience in pharmaceutical, biotechnology, medical device, CRO, or related industries • Foundational knowledge of GCP and other applicable GxP regulations focused on investigator sites • Spanish language skills at intermediate fluency • Demonstrated analytical and problem-solving skills • Strong written and verbal communication skills • Ability to manage multiple priorities collaboratively within project teams • Proficiency with Microsoft Office applications • Ability to sit or stand for extended periods at a stationary workstation • Ability to regularly carry, raise, and lower objects up to 10 lbs. • Ability to learn and comprehend basic instructions • Focus and attention to tasks and responsibilities

🏖️ Benefits

• Variable bonus eligibility in addition to base salary • Health coverage • Paid holidays • Other benefits • Professional development and continuous learning opportunities