Clinical Research Associate/Project Management

About the Role

Clinical Research Associate/Project Management position at Intrinseque Health.

Key Responsibilities

• Tracking study progress
• Managing essential documents
• Supporting regulatory submissions
• Contributing to risk assessment and mitigation plans for clinical operations and supply chain
• Preparing monitoring reports
• Supporting training of site personnel on study procedures
• Assisting with project planning and execution to maintain quality and operational efficiency

Qualifications

• Strong knowledge of clinical trial protocol development and implementation, including adherence to ICH-GCP and local regulatory guidelines.
• Experience as Clinical Research Associates and familiarity with site management, monitoring activities, and stakeholder coordination.
• Hands-on experience with Clinical Trials and Clinical Operations, including study start-up, conduct, and close-out phases.
• Solid Research skills, including data review, documentation accuracy, and issue identification and resolution.
• Bachelor’s or master’s degree in life sciences, pharmacy, nursing, or a related field.
• Strong organizational and project management abilities, with attention to detail and the capacity to manage multiple studies or tasks concurrently.
• Effective written and verbal communication skills, with the ability to collaborate in cross-functional and multicultural teams.