Senior Clinical Research Associate (CRA) I

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 and protocols.
• Manage study progress by tracking regulatory submissions, recruitment, enrollment, and CRF completion.
• 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 preferred (equivalent combination of education and experience may be accepted).
• At least 2 years of on-site monitoring experience.
• Strong knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Excellent written and verbal communication skills with fluency in English.
• 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.