Summary

The Quality Assurance (QA) Specialist plays a key role in maintaining and enhancing RIO's quality systems and regulatory compliance across all clinical research operations. This position is responsible for conducting internal audits, monitoring study documentation, and ensuring compliance with GCP, FDA, and ICH guidelines. The QA Specialist will work closely with site leadership, clinical operations, and regulatory staff to identify process improvements, prevent deviations, and uphold RIO's commitment to data integrity and excellence.

Job description

Position Summary

The Quality Assurance (QA) Specialist plays a key role in maintaining and enhancing RIO's quality systems and regulatory compliance across all clinical research operations. This position is responsible for conducting internal audits, monitoring study documentation, and ensuring compliance with GCP, FDA, and ICH guidelines. The QA Specialist will work closely with site leadership, clinical operations, and regulatory staff to identify process improvements, prevent deviations, and uphold RIO's commitment to data integrity and excellence.

Key Responsibilities

Conduct periodic internal audits of site documentation, regulatory binders, source data, and informed consent forms to ensure compliance with applicable regulations and company SOPs.
Develop, implement, and maintain RIO's QA policies, procedures, and corrective/preventive action (CAPA) systems.
Review monitoring visit reports, protocol deviations, and adverse event documentation for accuracy and consistency.
Collaborate with study teams to identify root causes and implement process improvements.
Assist with sponsor and regulatory inspections, including preparation, hosting, and post-inspection follow-up.
Maintain training records and ensure all staff are compliant with required GCP and SOP training.
Support continuous improvement initiatives, including SOP development, version control, and staff QA education.
Participate in risk assessments and quality trend analyses to proactively manage compliance risks.

Qualifications

Bachelor's degree in Life Sciences, Nursing, or a related field required.
2+ years of experience in clinical research, preferably in quality assurance, auditing, or regulatory compliance.
Strong working knowledge of GCP, FDA, and ICH guidelines.
Experience with CTMS, eReg, or EDC systems preferred (RealTime CTMS a plus).
Exceptional attention to detail, organization, and documentation accuracy.
Excellent communication and interpersonal skills; able to work collaboratively across departments.
Ability to handle multiple priorities in a fast-paced, deadline-driven environment.

Requirements

Bachelor's degree in Life Sciences, Nursing, or a related field
2+ years of experience in clinical research
Experience in quality assurance, auditing, or regulatory compliance preferred
Strong working knowledge of GCP, FDA, and ICH guidelines
Experience with CTMS, eReg, or EDC systems preferred
RealTime CTMS a plus
Exceptional attention to detail, organization, and documentation accuracy
Excellent communication and interpersonal skills
Ability to handle multiple priorities in a fast-paced, deadline-driven environment

Benefits

Health Insurance
Dental Insurance
Vision Insurance
401(k) Matching
Paid Time Off
Company Holidays

Company overview

Linical is a global Contract Research Organization (CRO) that provides comprehensive drug development services from early-phase research to large-scale multinational clinical trials. Founded in Japan and celebrating over 20 years of operation, the company has established itself as an award-winning CRO with a significant presence across all major markets including North America, Europe, and Asia-Pacific. With nearly 1,000 employees operating in 30+ countries, Linical offers a full spectrum of clinical development services including drug development strategy, clinical trial management, regulatory affairs, and therapeutic expertise across oncology, neurology, immunology, endocrinology, and other therapeutic areas. The company is recognized for its personalized approach to clinical trials, maintaining an impressive 85%+ client retention rate and consistently exceeding enrollment goals. Linical's operational model combines strong business perspective with clinical and medical expertise, providing flexibility and strategic guidance to help biopharmaceutical companies successfully navigate complex regulatory challenges and bring promising new therapies to patients worldwide.