Quality Assurance and Regulatory Compliance Associate

Quality Assurance and Regulatory Compliance Associate

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The Quality Assurance and Regulatory Compliance Associate is responsible for developing, implementing, and maintaining quality systems and regulatory compliance for human subject research conducted er the supervision of the Director, Clinical Research Operations, this role integrates regulatory oversight, quality assurance, and compliance management to ensure adherence to FDA, ICH-GCP, HIPAA, and institutional policies. The incumbent serves as a key liaison between research operations, sponsors, and regulatory authorities, providing expertise in clinical trial compliance, quality management, and staff education.

This role supports inspection readiness, oversees document control and SOP management, maintains research staff qualifications, and ensures data integrity and participant safety across all studies.

• Maintains regulatory compliance in all research activities in accordance with FDA, ICH-GCP, and OHRP regulations.
• Prepares, submits, and maintains regulatory documents including IND/IDE applications, annual reports, and study-specific submissions to regulatory agencies.
• Oversees and maintains Federal-wide Assurance (FWA) documentation and IRB registration.
• Manages clinical trials.gov entries under direction of Principal Investigators.
• Tracks and maintains documentation of research staff qualifications, training, licenses, and certifications.
• Oversees study record retention and archiving in accordance with FDA Title 21 CFR 312.62(c), including destruction schedules and offsite storage utilization.
• Maintains SDRI’s SOPs and guidelines to ensure compliance and consistency in research conduct, engaging subject matter experts in SOP development and revisions.
• Serves as Human Protections Associate and ensures ethical conduct and regulatory compliance in all research activities.
• Establishes and leads a quality assurance program that monitors compliance with regulatory requirements, GCP, and internal SOPs.
• Conducts internal quality audits of informed consent forms, source documentation, and regulatory binders for completeness and accuracy.
• Identifies and manages protocol deviations, noncompliance, and CAPAs (Corrective and Preventive Action Plans).
• Supports preparation for and participation in external inspections (FDA, sponsor, CRO, IRB) and leads post-inspection follow-up and documentation.
• Provides guidance on risk management and continuous process improvement.
• Develops and maintains systems for study tracking, project management, and performance reporting.
• Partners with IT and operations to ensure secure management of regulatory documents within systems such as Microsoft 365 and Veeva Site Vault.

• Provides training and quality assurance support to research staff.
• Develops and delivers GCP, compliance, and SOP training sessions.
• Collaborates with Human Resources and leadership to ensure HIPAA and research ethics training compliance.
• Supports staff management and supervision as requested by the Director of Research Operations.

• Serves as HIPAA compliance liaison, ensuring privacy and data protection practices are upheld across research activities.
• Partners with Managed Services Providers and HR to maintain security and privacy SOPs, staff training, and documentation of compliance.

• Maintains records of publications, abstracts, and clinical trial submissions.
• Reports issues of noncompliance to executive leadership and Human Resources.
• Attends and contributes to departmental and organizational meetings.
• Performs other duties as assigned.

• Working knowledge of FDA, ICH-GCP, OHRP, HIPAA, and related research regulations.
• Strong experience in quality management, internal auditing, and inspection readiness.
• Ability to interpret and apply regulatory requirements to operational processes.
• Excellent communication, organizational, and critical thinking skills.
• Ability to lead, train, and collaborate effectively across teams.
• Detail-oriented…