Clinical Research Associate

Roles & Responsibilities:
• Conduct site initiation, routine monitoring, and close-out visits to ensure compliance with study protocols, GCP, and regulatory requirements
• Build and maintain strong relationships with investigative sites, investigators, and study coordinators
• Perform routine monitoring visits to assess site performance, data integrity, and regulatory compliance
• Ensure timely resolution of data queries and issues identified during monitoring visits
• Ensure all study activities are conducted according to approved protocols, SOPs, and regulatory guidelines
• Collaborate with investigators to address and resolve protocol-related queries
• Assist in preparation and submission of regulatory documents to ethics committees and regulatory authorities
• Collaborate with data management teams for accurate and timely data collection and entry
• Perform source data verification and data validation activities
• Monitor and report adverse events as per regulatory and safety reporting procedures
• Provide training and support to site staff on study protocols, data collection, and regulatory compliance
• Act as a resource for investigators and site staff throughout the study

Qualifications:
• Bachelor’s degree in Life Sciences or a related field

Experience:
• Minimum 3 years as a Clinical Research Associate with proven site management and monitoring experience
• Familiarity with regulatory requirements and guidelines governing clinical trials

Skills:
• Excellent verbal and written communication skills
• Strong organizational and time management skills with attention to detail
• Ability to work effectively in cross-functional teams and independently
• Willingness to travel to investigative sites as required

About the Organization:
MS Clinical Research Pvt Ltd is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. The company focuses on conducting high-quality clinical trials, ensuring regulatory compliance, and supporting the development of innovative medical solutions in a collaborative and dynamic environment.