Senior Clinical Research Associate

Roles & Responsibilities
• Conduct site monitoring visits to ensure compliance with study protocol, ICH-GCP, regulatory requirements, and company SOPs
• Oversee Phase IV, PMS, and RWE studies to ensure data integrity, subject safety, and protocol adherence
• Perform site qualification, initiation, routine monitoring, and close-out visits as required
• Assess site performance, enrollment progress, and data quality; implement corrective actions when necessary
• Ensure timely and accurate source data verification (SDV) and query resolution
• Maintain inspection-ready documentation including essential documents and monitoring reports
• Collaborate with cross-functional teams including medical, safety, data management, and regulatory teams
• Provide training and ongoing guidance to site staff and junior CRAs
• Support vendor oversight and coordination with CRO partners where applicable
• Identify risks proactively and escalate issues to study leadership with mitigation strategies
• Ensure proper documentation, tracking, and reporting of study milestones and deliverables
• Independently manage multiple studies while meeting tight timelines

Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field
• Advanced clinical research certification (preferred)
• Master of Pharmacy (M.Pharm)

Experience
• 5+ years of overall experience in clinical research
• 2–3 years of CRA/monitoring experience in Phase II–IV trials
• Prior hands-on experience in PMS, RWE, or post-marketing studies is essential
• Experience working with CROs, external vendors, and cross-functional medical teams

Skills
• Strong knowledge of ICH-GCP, regulatory guidelines, and clinical trial conduct
• Excellent monitoring, documentation, and administrative skills
• Strong stakeholder management and communication abilities
• Ability to independently manage multiple concurrent studies
• High attention to detail and quality compliance mindset
• Strong problem-solving and risk management skills
• Proficiency in CTMS, EDC, and clinical trial systems
• Effective coordination and cross-functional collaboration skills

About the Organization
ICON plc is a global healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies in clinical development. ICON is committed to operational excellence, innovation, and building a diverse culture that rewards high performance while promoting well-being and work-life balance.