Sr. Clinical Research Associate

Roles & Responsibilities:
• Conduct and oversee site initiation, interim monitoring, and close-out visits according to study protocols, GCP, and applicable regulatory guidelines
• Build and maintain strong professional relationships with investigators, site coordinators, and key stakeholders
• Proactively identify and resolve site issues to ensure quality and compliance
• Perform comprehensive monitoring visits to assess site performance, data accuracy, and adherence to protocol
• Ensure timely follow-up on monitoring findings, query resolution, and documentation in compliance with SOPs
• Support risk-based monitoring activities and provide oversight to ensure data reliability
• Ensure all trial activities comply with study protocols, SOPs, and local/international regulations
• Participate in preparation and review of regulatory submissions and ethics committee communications
• Monitor, document, and report adverse events according to safety protocols and regulatory timelines
• Collaborate with data management and project teams to maintain high data quality and consistency
• Participate in internal and external audits, ensuring readiness and corrective actions as needed
• Provide ongoing training, mentoring, and support to site staff and junior CRAs
• Serve as a subject matter expert for protocol-related and operational queries

Qualification:
• Bachelor of Pharmacy, Master of Pharmacy
• Bachelor’s or Master’s degree in Life Sciences or a related field

Experience:
• Minimum 3 years as a Clinical Research Associate with demonstrated success in independently managing clinical sites

Skills:
• Strong understanding of ICH-GCP, local and international regulatory requirements, and clinical trial conduct
• Excellent communication and interpersonal abilities
• Strong analytical, organizational, and problem-solving skills
• Proficiency in documentation, reporting, and time management
• Ability to work independently and collaboratively within cross-functional teams
• Willingness to travel extensively to investigative sites

About the Organization:
MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific innovation and improving healthcare outcomes through high-quality clinical trials that meet global standards.