Research QA Specialist — Compliance & Training

CO010 Memorial Healthcare System; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Memorial Healthcare System is seeking a Research Quality and Assurance Specialist to ensure clinical research activities meet federal regulations, institutional policies, and ethical standards. You will provide quality oversight, conduct audits, support inspection readiness, and deliver training to research personnel.

You will collaborate with investigators, regulatory staff, and the IRB office to promote compliant research practices across the organization and drive continuous quality

Qualifications

• Three years of clinical research QA/audit experience required.
• Oncology or hematology research experience strongly preferred.
• Knowledge of regulatory requirements (ICH GCP, FDA CFR, HIPAA) required.

Responsibilities

• Schedules, coordinates and conducts project audits related to research non compliance and regulatory requirements.
• Performs source data verification of research documentation and issues queries as needed.
• Generates monitoring reports and communicates results to Principal Investigators and research teams.
• Manages post monitoring activities and CAPA follow‑up with minimal oversight.
• Develops, updates and maintains educational materials for research staff and delivers training.
• Reviews Informed Consent and Assent Forms for completeness and compliance.

Skills

Quality assurance

Auditing

Regulatory compliance

Training delivery

Project management

Documentation

Education

Bachelor's degree

Tools

Complion

Epic

REDCap

NCI CTSU systems

Job description

Memorial Healthcare System is seeking a Research Quality and Assurance Specialist to ensure clinical research activities meet federal regulations, institutional policies, and ethical standards. You will provide quality oversight, conduct audits, support inspection readiness, and deliver training to research personnel.

You will collaborate with investigators, regulatory staff, and the IRB office to promote compliant research practices across the organization and drive continuous quality