Clinical Research Associate I

Responsibilities

• Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits.
• Ensure clinical studies are conducted according to study protocols, applicable regulations, and sponsor requirements.
• 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 expectations.
• Evaluate the quality and integrity of study site practices and escalate quality issues as appropriate.
• Manage study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.
• Maintain appropriate documentation, including visit reports, follow-up letters, and Trial Master File (TMF) filings.
• Collaborate with study team members to support project execution and site financial management where applicable.

Requirements

• Bachelor's Degree in a scientific or healthcare discipline (or an equivalent combination of education and experience).
• Basic 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 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.