eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
OVERVIEW
The Quality Audit Coordinator serves as the central point for all sponsor, regulatory, supplier, and internal audits across the company’s eClinical solutions. The role safeguards continuous inspection readiness by organizing evidence, managing logistics before, during, and after each audit, and collaborating with departments across the entire Organization. Success is measured by complete and accurate audit files, on-time CAPA closure, and ongoing process improvements that streamline future inspections.
KEY TASKS & RESPONSIBILITIES
- Pre-audit coordination — assists with scheduling audits, confirm audit scope, assembles document packages, schedule interviews with subject-matter experts, and prepare on-site or virtual audit rooms.
- Live audit support — serve as primary scribe, manage real-time document requests, track question/response logs, and controls the flow of materials to auditors.
- Post-audit follow-up — compile meeting minutes, distribute observation summaries, assists in maintaining a findings tracker, and coordinate timely CAPA responses with owners.
- Maintain audit documentation — keep electronic folders and QMS trackers current, version-controlled, and compliant with retention requirements.
- Support internal quality audits — schedule, prepare, and close routine internal audits.
- Capture and verify records — document audit interviews accurately and circulate for stakeholder confirmation.
- Facilitate cross-functional readiness — ensure the various business units have evidence and answers prepared in advance.
- Assist with vendor audits — assist with coordinating assessments of third-party eClinical service providers and monitor follow-up actions.
- Improve audit processes — recommend and implement tools or workflow changes that reduce audit-prep time and strengthen documentation integrity.
- Update SOPs and work instructions related to audit management and inspection readiness.
- Perform additional duties as assigned to enhance the Quality Management System and maintain continuous inspection readiness.
Education & Experience
- Bachelor’s degree in a related field is preferred
- 3-5 years of experience working in a pharmaceutical industry is preferred.
- Knowledge of clinical trial terminology and process.
- Knowledge of GxP quality standards, applicable regulations, and software development risks.
Professional Skills
- Professionalism, confidentiality, and organization.
- Excellent writing and typing skills.
- High level of organizational skills and record-keeping.
- Ability to work effectively under critical deadlines.
- Robust communication skills and attention to detail.
Technical Skills
- Ability to pull reports or extract data when needed.
- Ability to easily learn various software applications.
- Experience with Qualio or other type of QMS tool
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
