Clinical Research Associate

About the Role

This is a full-time, on-site Clinical Research Associate role based in the United States.

Key Responsibilities

• Monitor clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Review source documents.
• Verify data accuracy in case report forms.
• Support investigators and site staff with trial conduct and documentation.
• Coordinate site initiation, monitoring, and close-out visits.
• Identify and resolve issues related to patient safety, data quality, and protocol compliance.
• Collaborate with clinical operations teams.
• Prepare reports.
• Contribute to continuous improvement in clinical research processes.

Requirements & Tech Stack

• Strong knowledge of clinical research protocols and guideline interpretation (Protocol).
• Experience in the Clinical Research Associate function and familiarity with CRA responsibilities and workflows.
• Expertise in managing and monitoring Clinical Trials, including patient safety, data integrity, and regulatory compliance.
• Solid Research skills, including data review, analysis, documentation, and reporting.
• Understanding of Clinical Operations, including site coordination, study timelines, and cross-functional collaboration.
• Knowledge of GCP and ICH guidelines.
• Ability to work on-site with investigational sites, travel as required, and collaborate professionally with investigators, coordinators, and internal teams.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
• Prior CRA or clinical research experience.
• Attention to detail.
• Strong organizational and time management abilities.
• Effective written and verbal communication.