Clinical Research Associate

Responsibilities

• Perform site monitoring visits, including selection, initiation, monitoring, and close-out, in accordance with GCP and ICH guidelines
• Work with sites to drive and track subject recruitment plans to enhance project predictability
• Administer protocol and related study training to assigned sites and manage ongoing project expectations
• Evaluate the quality and integrity of study site practices and escalate quality issues as appropriate
• Manage study progress by tracking regulatory submissions, recruitment, enrollment, and data query resolution
• Ensure site documents are available for the Trial Master File (TMF) and maintain the Investigator's Site File (ISF)
• Create and maintain documentation regarding site management, monitoring findings, and action plans
• Collaborate with study team members to support project execution and site financial management

Requirements

• Bachelor's Degree in a scientific discipline or healthcare (or an equivalent combination of education, training, and experience)
• Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Proficiency in Microsoft Office (Word, Excel, and PowerPoint)
• Strong written and verbal communication skills in English
• Excellent organizational and problem-solving skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.