Clinical Research Associate II

Role & Responsibilities
• Deliver high-quality, timely monitoring reports for sponsor approval as per the Clinical Monitoring Plan
• Monitor clinical trials remotely, onsite, or via approved methods ensuring patient safety and data integrity
• Plan and prioritize daily site monitoring activities based on study requirements
• Conduct site qualification, initiation, interim monitoring, and close-out visits
• Maintain Trial Master File (TMF) or electronic TMF (eTMF) in line with ICH-GCP Section 8 requirements
• Review site documentation for accuracy, completeness, and currency
• Ensure compliance with local regulations, GCP, and sponsor SOPs
• Submit travel and expense reports as per company guidelines

Qualification
• Bachelor’s degree in Pharmacy, Life Sciences, Nursing, Clinical, Science, or Health-related field
• B.Pharm / M.Pharm / Pharm.D / BSc / MSc (Life Sciences)
• Licensed healthcare professional (e.g., Registered Nurse) may be considered

Experience
• 2–5 years of prior clinical research experience
• Completion of a CRA training program or equivalent

Skills
• Strong understanding of clinical trial processes and GCP guidelines
• Knowledge of regulatory requirements and site monitoring practices
• Excellent documentation, organization, and communication skills
• Ability to work independently in a remote environment

Benefits
• Remote work flexibility and strong work-life balance
• Exposure to global biotech, medtech, and specialty pharma studies
• Career growth through international clinical monitoring experience
• Opportunity to contribute to life-changing therapies

About the Company
• Premier Research is a global CRO specializing in clinical monitoring and site management Partners with biotech, medtech, and specialty pharma companies worldwide