Clinical Research Associate II

Roles & Responsibilities:
• Deliver quality, timely monitoring reports for sponsor approval as per the Clinical Monitoring Plan
• Monitor clinical trials remotely, onsite, or via other approved methods, ensuring patient safety and data integrity in compliance with local regulations
• Plan and prioritize day-to-day clinical site monitoring activities per study requirements
• Conduct site qualification, study initiation, interim monitoring, and close-out visits as required
• Maintain Trial Master File (TMF) or electronic TMF (eTMF) following ICH/GCP Section 8 essential document requirements
• Review site documentation to ensure accuracy, completeness, and currency
• Submit travel and expense reports according to company guidelines

Qualification:
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field

Experience:
2 to 5 years in clinical monitoring or related CRA role

Skills:
Knowledge of ICH-GCP guidelines, clinical trial monitoring, TMF/eTMF management, site management, strong communication and organizational skills

About the Organization:
Premier Research is a global leader in clinical monitoring and site management, delivering innovative solutions for biotech, medtech, and specialty pharma projects. The company values employee contributions, supports career growth, and offers flexible work arrangements to maintain a healthy work-life balance.