Job Description: Clinical Research Associate II at IQVIA
Key Responsibilities:
✔ Conduct site monitoring visits (selection, initiation, monitoring, and close-out) in compliance with Good Clinical Practice (GCP) and regulatory guidelines.
✔ Collaborate with sites to drive subject recruitment and ensure study timelines are met.
✔ Provide protocol and study training to assigned sites and maintain effective communication.
✔ Ensure data integrity by reviewing case report forms (CRFs) and resolving queries.
✔ Track regulatory submissions, approvals, and study progress (enrollment, documentation, etc.).
✔ Maintain Trial Master File (TMF) and Investigator’s Site File (ISF) per GCP requirements.
✔ Prepare monitoring reports, follow-up letters, and essential study documentation.
✔ Support study start-up activities and site financial management (budgets, invoicing).
Skills & Qualifications:
✅ 3-6 years of experience in clinical site monitoring (CRA experience preferred).
✅ Strong knowledge of GCP, ICH guidelines, and local regulatory requirements.
✅ Degree in BAMS/BHMS/BDS/B.Pharma/M.Pharma or related life sciences field.
✅ Excellent communication, problem-solving, and organizational skills.
✅ Ability to work independently and collaborate with cross-functional teams.
About IQVIA
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. With a focus on innovation and data-driven healthcare solutions, IQVIA helps biotech, pharmaceutical, and medical device companies improve clinical outcomes worldwide.
🌟 Why Join IQVIA?
✔ Work with a Fortune 500 company in the healthcare analytics domain.
✔ Hybrid work model (flexible work arrangements).
✔ Career growth opportunities in clinical research and pharmacovigilance.
✔ Competitive salary & benefits as per industry standards.
