Quality Assurance Specialist

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