Quality Assurance Associate

Job Description:

Biopharma Informatic is seeking a detail-oriented and highly organized Quality Assurance Associate (QA Associate) to support quality oversight across all clinical research sites. This is an onsite role, and candidates must be local to the area.

The ideal candidate will have prior experience in clinical research quality assurance, monitoring preparation, chart review, and protocol compliance. This role requires strong analytical skills, meticulous attention to detail, and the ability to collaborate with site teams to maintain high-quality standards across all trials.

Key Responsibilities:

• Serve as the Quality Assurance representative across all company research sites.
• Ensure each clinical trial is conducted in accordance with study-specific protocols, GCP, and company SOPs.
• Review, update, and follow company Standard Operating Procedures (SOPs) annually (April) or as revised.
• Provide quality-focused training to Clinical Research Coordinators (CRCs).
• Participate in routine staff meetings and provide QA updates.
• Schedule and coordinate Interim Monitoring Visits (IMVs).
• Review and support resolution of all Interim Monitoring Reports (IMRs) and findings.
• Conduct detailed quality reviews of subject charts, source documents, and EDC entries to ensure accuracy and compliance.
• Perform quality checks prior to archiving and maintain corresponding logs.
• Assist with audit readiness and preparation for FDA, sponsor, and CRO audits.
• Maintain and routinely review the Clinical Trial Management System (CTMS).
• Maintain current GCP and applicable training certificates as required.
• Maintain up-to-date Informed Consent Form (ICF) logs for each protocol and ensure proper use at all sites.
• Collaborate with and work under the supervision of upper management.
• Perform any additional duties, tasks, or responsibilities as assigned by supervisors—verbally or in writing.

Qualifications

• 1–3 years of experience in clinical research quality assurance, monitoring, or regulatory affairs preferred.
• Strong working knowledge of GCP, ICH guidelines, FDA regulations, and clinical research processes.
• Experience reviewing subject charts, EDC entries, and source documentation.
• Exceptional attention to detail and strong analytical, documentation, and organizational skills.
• Ability to train and guide staff through quality expectations and corrective actions.
• Proficiency with CTMS platforms and standard office equipment.
• Excellent written and verbal communication skills.
• Must be local to the area (onsite only; no relocation or remote work).
• Ability to travel within Central Texas; occasional out-of-area travel may be required.