Clinical Research Associate - Remote

Overview

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world, providing expertise in clinical operations and enhancing patient safety through real-world and clinical analysis.

In Short

• Perform selection, initiation, monitoring, and closure visits at investigator sites.
• Monitor activities at clinical study sites for adherence to GCP, ICH, SOPs, and study protocols.
• Collect and review regulatory documents as required.
• Prepare site visit reports and telephone contact reports.
• Participate in the start-up process including reviewing protocols and developing study documents.
• Resolve site issues and determine status for Investigational Product shipment.
• Work with project managers and regulatory team members to secure authorization of documents.
• Attend and present at investigator meetings and study-specific training meetings.
• Participate in feasibility and site identification activities.
• Assist the project team with the day-to-day management of clinical studies.

Requirements

• Experience in clinical research and monitoring.
• Knowledge of GCP, ICH guidelines, and regulatory requirements.
• Strong communication and organizational skills.
• Ability to work independently and as part of a team.
• Proficiency in preparing regulatory documents.

Benefits

• Opportunity to work with leading pharmaceutical and medical device companies.
• Professional development and training opportunities.
• Collaborative work environment.
• Flexible working arrangements.