Biopharma Informatic · 2 days ago
Quality Assurance Associate
Houston, TX
Full-time
Onsite
Entry Level
1+ years expBiopharma Informatic is seeking a detail-oriented and highly organized Quality Assurance Associate to support quality oversight across all clinical research sites. The role involves ensuring compliance with clinical trial processes and providing quality-focused training while conducting detailed quality reviews.
BiotechnologyClinical Trials
Responsibilities
Serve as the Quality Assurance representative across all company research sites
Ensure each clinical trial is conducted according to study-specific protocols, GCP, ICH, and company SOPs
Review, update, and follow company Standard Operating Procedures (SOPs) annually (April) or as revised
Provide quality-focused training and support to Clinical Research Coordinators (CRCs)
Participate in routine staff meetings and deliver QA-related 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 for accuracy and compliance
Perform quality checks prior to archiving and maintain corresponding logs
Assist with audit readiness for FDA, sponsor, and CRO audits
Maintain and routinely review the Clinical Trial Management System (CTMS)
Maintain current GCP and other required training certifications
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 additional duties as assigned, verbally or in writing
Qualification
Required
1–3 years of experience in clinical research quality assurance, monitoring (CRA), clinical trial coordination (CRC), regulatory affairs, or clinical trial management (CTM)
Applicants with experience limited to manufacturing, laboratory QA, or non-clinical industries will not meet the qualifications for this role
Strong working knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes
Hands-on experience reviewing subject charts, EDC entries, and source documentation
Exceptional attention to detail and strong analytical, documentation, and organizational skills
Ability to train staff, support corrective actions, and reinforce quality expectations
Proficiency with CTMS platforms and general office technology
Excellent written and verbal communication skills
Must be local to the area (onsite only; no relocation or remote options)
Ability to travel within Central Texas; occasional additional travel may be required
Company
Biopharma Informatic
Biopharma Informatic is a clinical research company that provides clinical trials and prepares documentation on different protocols.
51-200 employees
H1B Sponsorship
Biopharma Informatic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (4)
2023 (2)
2022 (2)
2020 (2)
Funding
Current Stage
Growth StageLeadership Team
Shuja Naqvi
Chief Executive Officer
Company data provided by crunchbase