Shilvi Meshram

With my background in clinical research, Clinical data management & Pharmacovigilance and a proven track record in clinical trial coordination, I believe that I would be a valuable addition to your team.

       As a seasoned Clinical Research Coordinator, I have successfully managed and coordinated clinical trials, ensuring strict adherence to protocols and regulatory requirements. During my tenure, I have been responsible for managing and conducting clinical trials, ensuring compliance with ICH-GCP guidelines, and conducting sponsor monitoring and QA audits to maintain the highest standards of quality in our clinical trials.I am confident that my experience has equipped me with the skills necessary to transition seamlessly into a Clinical Research Associate role. I am adept at monitoring patient safety & ensuring data integrity. Moreover, my commitment to maintaining the highest standards of research integrity aligns perfectly with your company's mission

Job Responsibilities:

  To assist and co-ordinate Principal Investigator and study staff in conducting ethically sound clinical trial at assigned investigational site. 

 Ensuring the conduct of the trials as per the Protocol, ICH GCP and other relevant SOP’s.

  To assist study monitor during routine monitoring visits and resolution of monitoring actions

  Regular co-ordination with study monitor & other study personnel for study updates & progress at site 

 e-CRF data entry as per the source documents & timely query resolution

 Coordinate EC submission and notification

  Maintain and update ISF as well ensure that the patient files, source documents and running logs are real time updated. 

 Handling administrative and logistics work for the study at site level. 

 Central/local lab coordination’s.

  Investigation Product (IP) handling and accountability.

  Ensure adequate clinical supplies availability at site at all times. 

 Ensuring that all the adverse events are documented and reported in compliance with safety procedures and timelines.

1)Post graduate Diploma in Clinical Research, Clinical Data Management & Pharamacovigilance

2)M.Sc in Molecular Biology & Genetic Engineering

3)B.Sc in Biotechnology