Clinical Research Quality Assurance Specialist

Quality Assurance Specialist - Job DescriptionThe Quality Assurance Specialist is responsible for ensuring compliance with regulatory guidelines, institutional policies, and industry best practices. This role involves supporting clinical research activities by developing, reviewing, and maintaining essential quality assurance documentation, performing internal audits, and providing guidance on compliance-related matters. The Quality Assurance Specialist works closely with clinical teams, investigators, and research staff to maintain high standards of research integrity and operational excellence.Key Responsibilities:Regulatory Compliance & Documentation: Maintain an expert understanding of FDA CFRs, GCP, and ICH guidelines while ensuring compliance with evolving regulatory requirements.Source Documentation Management: Create, review, and update electronic and paper-based source documents to align with protocol requirements and amendments.Quality Audits & Monitoring: Conduct internal audits of study documentation, Investigator Site Files (ISF), and regulatory records to identify and resolve compliance issues.Process Improvement & SOP Development: Assist in the creation and refinement of Standard Operating Procedures (SOPs) to enhance site quality assurance processes.Data Review & Subject Eligibility: Review subject screening data and eligibility criteria before randomization or invasive procedures to ensure protocol adherence.Trend Analysis & Reporting: Conduct targeted quality reviews to identify trends and provide recommendations for process improvements and staff training.Meeting Participation: Attend and contribute to QA team meetings, prepare meeting minutes, and support cross-functional collaboration.Regulatory Support: Assist in regulatory submissions, protocol deviation reports, and other documentation required for IRB submissions.Adverse Event & Protocol Compliance: Support the identification, documentation, and reporting of protocol deviations, adverse events, and corrective actions.Interdepartmental Collaboration: Work closely with clinical, regulatory, and operations teams to ensure quality standards are maintained throughout all research activities.Training & Development: Provide guidance and support to clinical research staff regarding best practices in documentation, compliance, and protocol adherence.Travel & Site Support: Attend meetings and occasionally travel to other research sites, which may include overnight stays.Additional Duties: Perform other tasks as assigned to support business needs and research operations.Knowledge, Skills, and Abilities:Regulatory Expertise: Strong understanding of clinical research regulations, including FDA, GCP, and ICH guidelines.Attention to Detail: Ability to detect and correct errors in documentation and study-related materials.Organizational & Time Management Skills: Ability to manage multiple tasks efficiently and work in a fast-paced environment with minimal supervision.Communication & Collaboration: Strong written and verbal communication skills; ability to work effectively with diverse teams.Problem-Solving Ability: Capability to assess quality issues and provide actionable solutions to improve compliance and efficiency.Confidentiality & Ethics: Ability to handle sensitive information appropriately and ensure compliance with ethical research guidelines.Technical Proficiency: Proficient in Microsoft Office Suite, regulatory software (e.g., Veeva, Complion, CRIO), EDC systems, and electronic medical record platforms.Required Experience and Qualifications:Education: College or advanced degree preferred in a healthcare, scientific, or regulatory-related field.Experience: Minimum of 3+ years of experience in a clinical research environment with direct involvement in quality assurance or regulatory compliance.Preferred Qualifications: Experience with FDA inspections, regulatory audits, or sponsor/CRO site inspections is highly desirable. Experience with electronic source creation and documentation. Travel: 30-40% travel commitment; this position is remote, but travel will be expected to company sites for training, audits, team collaboration, and other operational needsThis position is ideal for someone who is detail-oriented, proactive, and committed to upholding high standards in clinical research quality assurance. The Quality Assurance Specialist plays a crucial role in ensuring compliance and supporting the success of clinical trials.

Created: 2025-06-04