02 Oct
|
MS CLINICAL RESEARCH
|
Bengaluru
02 Oct
MS CLINICAL RESEARCH
Bengaluru
Job Title: Clinical Research Associate (CRA)/ Senior Clinical Research Coordinator Company: MS Clinical Research Pvt Ltd
Experience: Minimum 3 years
MS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of excellence and contribute to the development of breakthrough medical solutions.
We are seeking an experienced and proactive Clinical Research Associate (CRA/ Sr.CRC) with a minimum of 5 years of relevant experience in clinical trial monitoring and site management. The CRA will be responsible for overseeing the conduct of clinical trials, ensuring regulatory compliance, maintaining data integrity, and mentoring junior CRAs and CRCs. Conduct and oversee site initiation, interim monitoring, and close-out visits in accordance with study protocols, GCP, and applicable regulatory guidelines.
Proactively identify and resolve site issues to ensure quality and compliance.
Clinical Trial Monitoring
Perform comprehensive monitoring visits to assess site performance, data accuracy, and adherence to protocol.
Ensure timely follow-up on monitoring findings, query resolution, and documentation in compliance with SOPs.
Support risk-based monitoring activities and provide oversight to ensure data reliability.
Protocol & Regulatory Compliance
Ensure that all trial activities comply with study protocols, SOPs, and local/international regulations.
Participate in the preparation and review of regulatory submissions and ethics committee communications.
Stay updated on evolving regulatory requirements and communicate changes to project teams.
Data & Quality Management
Oversee source data verification and ensure timely data entry and validation.
Collaborate with data management and project teams to maintain high data quality and consistency.
Monitor, document, and report adverse events in accordance with safety protocols
📌 Research Associate (Bengaluru)
🏢 MS CLINICAL RESEARCH
📍 Bengaluru