Clinical Research QA Specialist — Audits & Training

Memorial Healthcare System; Florida; Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

Memorial Healthcare System seeks a Research Quality and Assurance Specialist to oversee clinical research quality, compliance, and training across the organization. The role ensures adherence to federal regulations, institutional policies, and ethical standards while supporting inspections readiness and investigator collaboration.

Responsibilities include audits, source data verification, CAPA follow-up, and development of educational materials for research staff to promote high-quality,

Formación

• Minimum of three (3) years of clinical research experience with monitoring, auditing or QA/QC responsibilities.
• Oncology and/or Hematology research experience strongly preferred.

Responsabilidades

• Schedules, coordinates and conducts project audits related to research non-compliance, high risk, or random investigator protocols.
• Performs source data verification of research documentation and confirms adherence to SOPs and regulatory requirements.
• Generates monitoring reports and communicates results to investigators and leadership; manages CAPA follow-up.
• Develops and maintains training materials; delivers in-person and virtual sessions for researchers and staff.
• Reviews informed consent forms for completeness and regulatory compliance; documents and corrects as needed.
• Provides QA/QC support to ensure data integrity and identifies process improvements for research operations.

Conocimientos

QA/QC

Auditing

Regulatory compliance

Training

Educación

Bachelor's degree

Herramientas

Complion

Epic

REDCap

NCI CTSU

Descripción del empleo

Memorial Healthcare System seeks a Research Quality and Assurance Specialist to oversee clinical research quality, compliance, and training across the organization. The role ensures adherence to federal regulations, institutional policies, and ethical standards while supporting inspections readiness and investigator collaboration.

Responsibilities include audits, source data verification, CAPA follow-up, and development of educational materials for research staff to promote high-quality,