Specialist - Research Quality and Assurance

Complexity of Work:

This role requires professional judgment, decision making, and deep expertise in clinical research regulations and quality systems. Work involves analyzing nuanced documentation, performing detailed data verification, and managing CAPA follow up with minimal oversight. The position influences institutional research practices through expert guidance, cross functional collaboration, and development of training and educational materials. Decisions made in this role directly impact regulatory readiness, research integrity, and organizational risk. Thorough knowledge of regulatory requirements for clinical research, including

ICH GCP, FDA CFR, HIPAA, IRB

processes, and institutional SOPs. Knowledge of basic human anatomy, physiology, and medical terminology.

Required Work Experience:

A minimum of three (3) years of clinical research experience with monitoring, auditing, or QA/QC responsibilities required.

Oncology and/or Hematology research experience strongly preferred.

Other Information:

Additional Education Info:

Bachelors degree in science, healthcare, or a related medical field; RN degree preferred.

Knowledge of Complion (E-Regulatory system), Epic (EMR) and REDCap Database preferred.

Familiarity with

NCI CTSU

systems, cooperative group research processes, for Clinical Trials in Oncology requirements preferred.

SOCRA (CCRP) or (ACRP) certification preferred. Memorial Healthcare System is a community of caregivers dedicated to delivering quality patient- and family-centered care. This passion for caring extends to our teammates, who support one another and create heartfelt connections that last a lifetime. We are one family at the heart of exceptional care. Join us as we elevate the well-being of everyone we touch. #teamMHSflorida