Supriya Nale Email & Phone Number

Ahmedabad, Gujarat, India

- Conduct site initiation, routine monitoring, and closeout visits to ensure compliance with study protocols, GCP, and regulatory requirements.- Collaborate closely with investigators, study coordinators, and site personnel to facilitate smooth trial execution and timely data collection. - Perform source data verification, adverse event reporting, and query resolution to ensure accurate and complete data sets.- Provide comprehensive support in document management, including TMF maintenance and submission preparation.- Proactively identify issues and risks, and develop appropriate strategies to mitigate them, contributing to the success of trials.

Pune, Maharashtra

- Works with the investigator to manage the day to day activities of the study including problemsolving, communicanication and protocol management.- Make a recruitment strategy for patient recruitment in the trial.- Assess patients for protocol eligibility, coordinate, evaluate, and follow patients participationin clinical trials.- Overseeing the day to day operations of clinical trials and studies as per the ICH GCPguidelines/Regulatory authority guidelines.- Collects documents needed to initiate the study and submit to the sponsor ( e.g., FDA Forms1572, CVs, etc )- Prepared ethics committee submission, approval and notifications in a timely manner, amendment’s in study, study notification and SAE related documents to ethics committee/regulatory authorities.- Participate and prepare for site qualification visits, site initiation visits, site monitoring visitsand site close out visits.- Communication with Ethics Committee,Sponsor and CRO.

Bsc Biotechnology, Biotechnology

Post Graduation Diploma, Clinical Research

Activities and Societies: Clinical Trials, ICH GCP, Regulatory Requirements