Job Opportunity: Clinical Trial Associate II

Job Summary:
Premier Research is seeking a detail-oriented and motivated Clinical Trial Associate II to join our Global Clinical Monitoring and Site Management team in Bangalore, India. In this role, you will be instrumental in supporting the lifecycle of clinical trials by managing essential documentation, maintaining trial master files, and ensuring rigorous regulatory compliance. This position is ideal for a dedicated clinical research professional looking to advance their career within a leading global Contract Research Organization (CRO) that partners with biotech, medtech, and pharmaceutical innovators to deliver life-saving therapies.

Job Responsibilities

TMF & Document Management

• Maintain the Trial Master File (TMF) and electronic Trial Master File (eTMF) in full compliance with sponsor SOPs and regulatory standards.
• Develop and manage filing structures and placeholders aligned with TMF filing plans.
• Conduct comprehensive quality reviews of site documentation to ensure adherence to ALCOA+ principles and regulatory requirements.
• Perform completeness checks during study startup, maintenance, and close-out phases.
• Proactively resolve TMF queries and generate reports to monitor study quality and regulatory readiness.

Clinical Systems & Data Management

• Assist in the setup and daily data entry for Clinical Trial Management Systems (CTMS).
• Maintain accurate records for site contacts, activation status, and vendor activities.
• Track the distribution of critical documents, including Investigator’s Brochures and safety reports.
• Manage user access and system permissions for platforms such as EDC, IWRS, and various vendor systems.
• Monitor training compliance matrices for clinical team members.

Study Coordination & Operational Support

• Provide robust support to Clinical Research Associates (CRAs) and study teams regarding essential document collection and review.
• Coordinate logistics with vendors for site equipment, translations, and essential study materials.
• Facilitate the preparation of Investigator Site Files (ISF) and pharmacy files in anticipation of Site Initiation Visits.
• Support project tracking tools, including Q&A logs and issue tracking sheets.
• Identify operational bottlenecks and escalate issues to project management or leadership.
• Mentor and provide guidance to junior team members as needed.

Requirements

Educational Qualifications

• An undergraduate degree in Life Sciences, Nursing, Medical Documentation, Clinical Research, or a related healthcare discipline.
• Note: Equivalent education and significant relevant experience may be considered in lieu of a degree.

Professional Experience

• A minimum of 1 year of experience as a Clinical Trial Associate (CTA) or in a similar clinical research operations role.

Skills and Competencies

• Solid understanding of ICH-GCP guidelines and clinical trial essential documentation.
• Practical knowledge of ALCOA+ data integrity principles.
• Proficiency in clinical research systems (e.g., CTMS, EDC, IWRS).
• Advanced MS Office skills (Word, Excel, PowerPoint, Outlook).
• Strong organizational, time management, and interpersonal communication skills.
• Proven ability to work effectively both independently and within cross-functional, collaborative team environments.

Benefits

• Competitive Compensation: Estimated salary range of ₹6,00,000 – ₹10,00,000 per year, commensurate with industry benchmarks.
• Work-Life Balance: Hybrid work model designed to support flexibility.
• Career Growth: Exposure to global clinical research operations with a leading CRO.
• Professional Development: Access to formal training programs and career progression pathways.
• Environment: Opportunity to work in a collaborative, international research culture focused on medical innovation.

How to Apply

If you are a driven professional passionate about clinical research and eager to contribute to the delivery of life-saving medical solutions, we invite you to apply.

Please visit the official Premier Research careers portal to submit your application and view the full details of this position. We look forward to reviewing your qualifications and discussing how your background fits our team’s mission.