Clinical Research Associate

Roles & Responsibilities
• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with GCP and ICH guidelines.
• Work with sites to drive and track subject recruitment plans to meet project needs and enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular communication to manage project expectations and issues.
• Evaluate the quality and integrity of study site practices and adherence to regulations, escalating quality issues as necessary.
• Track the progress of assigned studies, including regulatory submissions, recruitment, CRF completion, and data query resolution.
• Ensure site documents are available for filing in the Trial Master File (TMF) and ensure Investigator's Site File (ISF) is maintained according to GCP/ICH and local requirements.
• Create and maintain documentation regarding site management and monitoring visit findings, submitting regular reports and follow-up letters.
• Collaborate with study team members for project execution support as needed.
• If applicable, support development of site-specific subject recruitment plans and manage site financials per clinical trial agreements.

Qualification
• Relevant qualification in life sciences, clinical research, or related fields.

Experience
• 3+ years of relevant experience in Clinical Research.

Vacancies
• Multiple positions available in Bangalore, Mumbai, Ahmedabad, and Delhi.

Skills
• Strong knowledge of GCP, ICH, and regulatory guidelines.
• Excellent communication and interpersonal skills.
• Ability to manage site monitoring, recruitment, and data queries effectively.
• Experience with Trial Master File (TMF) and Investigator's Site File (ISF).
• Strong organizational skills and ability to track study progress.

About the Company
IQVIA India is a global leader in healthcare data and analytics, providing solutions to help clients in the pharmaceutical, biotechnology, and healthcare industries. IQVIA’s mission is to enable healthcare organizations to navigate complex data, deliver insights, and improve patient outcomes through advanced technology and clinical expertise.