Quality Assurance Specialist
About The Position
Elevate Clinical Research is a mission‑driven organization expanding access to high‑quality clinical trials across Texas, Louisiana, Illinois, Maryland, Kansas, and growing. We exist to bring research closer to the communities that that need it most, delivering compassionate patient care, operational excellence, and trustworthy data that advances medicine. At Elevate, your work has real impact. Every role contributes directly to improving health outcomes and bringing new therapies to life. We hire people who care deeply about patients, believe in doing things the right way, and want to grow with a company that’s expanding nationwide. What We Value Patients first in every decision and interaction Access, equity, and bringing research to underserved communities High‑quality, compliant, reliable study execution Purpose‑driven growth and opportunities for advancement Supportive teams who communicate, collaborate, and care Why People Join Us A mission that matters Clear, structured onboarding Leadership that listens and supports Career growth as we expand into new states A culture built on integrity, teamwork, and accountability Join Elevate and help build a patient‑centered research network that’s changing what clinical trials can look like for communities across the country.
Requirements
- Bachelor’s degree in life sciences, healthcare, or related field
- 2–4+ years of experience in clinical research (CRC, Regulatory, or QA role)
- Strong knowledge of GCP, ICH guidelines, and clinical trial processes
- Experience reviewing source documents, regulatory binders, or data
- Attention to detail / audit mindset
- Strong understanding of clinical protocols and documentation standards
- Problem-solving and root cause analysis
- Ability to hold teams accountable while maintaining a collaborative approach
- Continuous improvement mindset
Nice To Haves
- QA, Regulatory, or monitoring experience in a clinical research setting
- Experience with CTMS, eSource, and eReg systems (e.g., CRIO)
- ACRP or SOCRA certification
Responsibilities
- Conduct routine and random QA reviews of patient charts, source documents, and regulatory files to ensure accuracy, completeness, and protocol adherence
- Verify data integrity across eSource, eReg, and case report forms
- Identify discrepancies, protocol deviations, and documentation gaps, escalating as needed
- Maintain detailed records of QA findings and corrective actions
- Ensure adherence to GCP, ICH guidelines, FDA regulations, and internal SOPs
- Support audit and inspection readiness by ensuring documentation is complete and organized
- Partner with site staff to resolve compliance issues and implement corrective/preventive actions (CAPAs)
- Monitor staff training compliance and documentation requirements
- Identify trends in QA findings and recommend operational improvements
- Standardize and improve workflows to enhance quality and consistency across sites
- Assist in development and updates of SOPs and quality processes
- Contribute to continuous improvement initiatives across departments
- Work closely with Clinical Research Coordinators (CRCs), Regulatory, and Data teams to ensure alignment
- Provide guidance and feedback to site staff regarding documentation and protocol compliance
- Support feasibility, data quality initiatives, and study start-up activities as needed
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
