Clinical Research Associate II - Remote

Overview

The Clinical Research Associate II is responsible for conducting site visits, ensuring compliance with regulatory requirements, and monitoring clinical trials across various therapeutic areas.

In Short

• Conduct site visits including selection, initiation, monitoring, and close-out.
• Monitor patient safety, data integrity, and protocol adherence.
• Ensure accurate study documentation and adherence to Good Documentation Practices.
• Manage multiple protocols and therapeutic areas.
• Provide training and support to site staff.
• Review case report forms and electronic data capture systems.
• Maintain communication with investigators and internal teams.
• Assist in resolving site-specific issues and queries.
• Support in ethics submissions and regulatory documentation.
• Contribute to process improvement and adherence to SOPs.

Requirements

• Minimum 2 years’ independent monitoring experience in clinical research.
• Strong understanding of ICH-GCP and regulatory guidelines.
• Experience in sponsor-dedicated and multi-sponsor settings preferred.
• Ability to manage multiple sites and protocols.
• Excellent communication and problem-solving skills.
• Ability to travel for site monitoring visits.
• Degree in Life Sciences, Pharmacy, Nursing, or related field.

Benefits

• Competitive salary.
• Opportunities for professional development.
• Supportive work environment.
• Access to training and resources.
• Health and wellness programs.
• Flexible working arrangements.