CRA 2

Responsibilities

• Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits, in accordance with Good Clinical Practice (GCP).
• Work with sites to drive and track subject recruitment plans to enhance project predictability.
• Administer protocol and study training to assigned sites and maintain regular communication to manage project expectations.
• Evaluate the quality and integrity of study site practices and ensure adherence to applicable regulations.
• Manage study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.
• Ensure site documents are properly filed in the Trial Master File (TMF) and that the Investigator's Site File (ISF) is maintained.
• Create and maintain documentation regarding site management, including visit reports and follow-up letters.
• Collaborate with study team members to support project execution and site financial management where applicable.

Requirements

• Bachelor's Degree in a scientific discipline or healthcare field.
• Minimum of 1.5 years of on-site monitoring experience.
• Availability to travel for on-site monitoring duties.
• Strong knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Fluency in English (both written and verbal communication).
• Strong organizational, problem-solving, and time management skills.

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.