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Baptist Memorial Health Care · 1 day ago

Clinical Research Quality Assurance Monitor III

Memphis, TN

Full-time

Hybrid

Mid Level

4+ years exp

Baptist Memorial Health Care is seeking a Clinical Research Quality Assurance Monitor III responsible for overseeing the quality assurance of various clinical studies. This role ensures compliance with study protocols, regulatory requirements, and Good Clinical Practice while conducting internal monitoring and participating in external audits.

GovernmentHealth CareHospitalMedicalNon ProfitNursing and Residential CareRehabilitationWellness

Responsibilities

Perform routine and ongoing internal clinical study monitoring to ensure adherence to protocols, regulatory requirements, GCP, and institutional SOPs

Conduct regular site visits, including onboarding new research staff, verifying participant eligibility, performing timely research chart reviews, and executing source data verification

Review training records to confirm that research staff and sites maintain compliance with required training curricula

Provide project-specific compliance support, including review of study protocol requirements, GCP/compliance inquiries, essential document development/review, Corrective and Preventive Action (CAPA) plan development, and audit/inspection support

Work closely with study investigators and research teams throughout the monitoring and auditing process, offering guidance and real-time education when significant concerns or issues are identified

Meet with investigators and research teams to review monitoring findings and develop CAPA plans as needed

Assist clinical research staff in preparing and verifying responses to queries generated from study protocol monitoring

Collaborate with QA Leadership to draft monthly and quarterly summary reports

Discuss potential workflow improvements, evaluate verification procedures, and implement quality assurance and risk assessment/reduction strategies to ensure research compliance

Contribute to the development and refinement of research quality assurance processes

Perform other duties as assigned to support the organization’s clinical research objectives

Qualification

Clinical research experienceGCP knowledgeFDA regulations knowledgeMedical terminologyOncology focusEMR proficiencyEDC proficiencyInterpersonal skillsWriting skillsDetail orientedOrganizational skillsCritical thinkingProblem solving

Required

4 years of clinical research experience in a clinical research organization, research site, pharmaceutical/device industry, or site management organization, preferably with some Oncology focus (other areas acceptable)

Intermediate skills in medical/research chart review, investigator site file review, and using EMR, EDC, Excel, Word, and PowerPoint

Master's degree, preferably in Science or a Health-related field

Able to manage competing and shifting priorities

Knowledge of medical terminology

Intermediate knowledge of FDA-regulated research, ICH Guidelines, and GCP

Detail oriented, highly organized, and able to think critically and problem solve

Strong interpersonal and writing skills

Ability and availability to travel to Metro area sites and Tri-State area sites (TN, MS, AR) and travel for training

Some overnight stay may be required