About Company:
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 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.
Position Summary:
The Quality Assurance (QA) Specialist is responsible for ensuring clinical research activities are conducted in compliance with study protocols, regulatory requirements, and internal SOPs. This role plays a critical part in maintaining audit readiness, identifying quality risks, and driving continuous improvement across site operations. The QA Specialist will perform routine reviews, support inspections, and partner with site teams to ensure high standards of data integrity and patient safety.
Key Responsibilities
Quality Assurance & Review
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
Compliance & Regulatory Oversight
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
Process Improvement
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
Cross-Functional Support
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
Required Qualifications:
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
Preferred Qualifications:
QA, Regulatory, or monitoring experience in a clinical research setting
Experience with CTMS, eSource, and eReg systems (e.g., CRIO)
ACRP or SOCRA certification
Core Competencies
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