CRA- Clinical Research Associate Bioagile Therapeutics Pvt. Ltd

About Bioagile Therapeutics Pvt. Ltd

Job Description

Oversee and manage clinical trials from initiation to closure, ensuring compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. Identify and assess potential clinical trial sites; conduct pre-study, site initiation, routine monitoring, and close-out visits. Ensure clinical sites are adequately equipped and staffed, and monitor site performance for accurate and complete data collection. Review and verify data from clinical sites for accuracy and completeness; ensure timely and accurate entry into clinical databases. Address data queries and discrepancies in collaboration with clinical sites and the data management team. Prepare and submit necessary regulatory documents, including ethics committee submissions and regulatory authority applications. Maintain essential documents and study files in compliance with regulatory and company standards; ensure proper documentation of study activities. Provide training and support to clinical site staff on study protocols, procedures, and GCP requirements. Serve as the primary contact for clinical sites, addressing questions and resolving study-related issues. Communicate regularly with study sponsors, project managers, and stakeholders on study progress and site performance. Prepare and present study progress reports, including updates on patient enrollment, data quality, and regulatory compliance. Identify and address potential risks and issues impacting study quality or timelines; implement corrective and preventive actions as needed. Contribute to the development and improvement of clinical research processes and standard operating procedures (SOPs). Stay updated on industry trends, new regulations, and best practices in clinical research. Job Type: Full-time Benefits: Health insurance Schedule: Day shift Experience: total work: 2 years (Required),