Specialist - Research Quality and Assurance

Memorial Healthcare System; Florida; Vor Ort; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

Memorial Healthcare System is seeking a seasoned clinical research professional in Florida with strong expertise in regulatory requirements, quality systems, and data integrity. The role involves expert guidance, cross-functional collaboration, and developing training materials to support research programs.

Candidates should have at least three years of monitoring, auditing, or QA/QC experience, familiarity with Complion, Epic, and REDCap, and a preference for RN credentials or professional

Qualifikationen

• Bachelor's degree in science, healthcare, or related field; RN degree preferred.
• A minimum of three (3) years in clinical research with monitoring, auditing, or QA/QC responsibilities.
• SOCRA (CCRP) or ACRP certification preferred.

Aufgaben

• Provide expert guidance on regulatory requirements and quality systems.
• Monitor, audit, and verify trial data; manage CAPA follow-up with minimal supervision.
• Collaborate cross-functionally to influence research practices and training materials.

Kenntnisse

Regulatory knowledge

ICH GCP

Data verification

CAPA management

Clinical research

Ausbildung

Bachelor's degree in science/healthcare

RN degree preferred

Tools

Complion

Epic

REDCap

NCI CTSU familiarity

Jobbeschreibung

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: Bachelor's 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