Senior Clinical Monitoring Lead

CTI Clinical Trial and Consulting Services; Covington (KY); Presencial; USD 100.000 - 140.000; Jornada completa

Descripción de la vacante

CTI Clinical Trial and Consulting Services seeks an experienced Senior CRA/Lead for our Clinical Monitoring team. You will review project scope, plan monitoring activities, and implement project-specific standards with KPIs and metrics.

You will mentor CRAs, coordinate training, and serve as the primary monitoring contact for key projects. You will oversee CRA performance, ensure timely data quality in eDC and TMF, escalate issues, and collaborate with sponsors and sites to optimize trial

Formación

• Bachelor’s degree or higher in allied health or related field; RN with certification also acceptable.
• 8+ years as CRA or related clinical research experience as deemed by hiring manager.
• Experience as Lead CRA for at least 1 year.
• Strong knowledge of ICH/GCP and regulatory requirements.

Responsabilidades

• Review scope of project and resourcing related to Clinical Monitoring with Clinical Project Management.
• Plan, schedule, and implement the clinical monitoring aspects of projects.
• Define and implement project-specific standards with KPIs, KRIs, QTLs and metrics.

Conocimientos

CRA leadership

ICH/GCP knowledge

Mentoring

Communication skills

Risk assessment

Project monitoring

Educación

Bachelor's degree or higher in allied health or related field

Herramientas

CTMS

eTMF

EDC

MS Office

Descripción del empleo

CTI Clinical Trial and Consulting Services seeks an experienced Senior CRA/Lead for our Clinical Monitoring team. You will review project scope, plan monitoring activities, and implement project-specific standards with KPIs and metrics.

You will mentor CRAs, coordinate training, and serve as the primary monitoring contact for key projects. You will oversee CRA performance, ensure timely data quality in eDC and TMF, escalate issues, and collaborate with sponsors and sites to optimize trial