Durwas Motghare

Clinical Research Associate @Lupin

Mumbai, IN

As a Clinical research associate working on global clinical trials of Phase-II, and Phase-IV.>Site Selection and Qualification: CRAs participate in selecting and qualifying investigative sites for clinical trials. This involves evaluating site capabilities, assessing adherence to protocols and regulations, and ensuring that sites have the resources and expertise to conduct the trial effectively.> Study Start-Up Activities: CRAs assist in initiating clinical trials by coordinating with investigative sites to ensure all essential documents and regulatory approvals are obtained. This includes preparing and reviewing study documents such as protocols, investigator brochures, and informed consent forms.> Site Monitoring and Management: CRAs conduct regular visits to investigative sites to monitor the progress of clinical trials and ensure compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This involves reviewing study documentation, verifying data accuracy, and addressing any issues or deviations that may arise.> Data Collection and Review: CRAs oversee the collection and management of clinical trial data, ensuring accuracy, completeness, and timeliness. They may also assist in data review and query resolution to ensure data quality and integrity throughout the trial.> Safety Monitoring: CRAs are responsible for monitoring the safety of trial participants and ensuring that adverse events are reported and managed according to protocol and regulatory requirements. This involves reviewing safety data, assessing risks, and communicating with investigative sites and study sponsors as needed.> Quality Assurance and Compliance: CRAs ensure that clinical trials are conducted in compliance with applicable regulations, guidelines, and quality standards. They may participate in internal and external audits to assess and address compliance issues and ensure the integrity of trial data.

Sant Gadge Baba Amravati University, Amravati

Bachelor of Pharmacy - B. Pharm

Sant Gadge Baba Amravati University, Amravati

M. Pharmacy