Nse A

About Nse A

Albert has over 8 years’ experience as a Clinical Research Associate monitoring phases I,…

Experience

1. Clinical Research Associate Ii

   Pra Health Sciences

   Mar 2017 — Present

   Clinical Research Associate II 03/2017 to Current PRA Health Science – Providence, RI • Acts as primary point of contact for specific vendors investigational site as needed. • Conducts periodic review of metrics for completion of study files in the eTMF. Escalates appropriately to the CPM and study team of updates and timelines regarding file completion. •Participates in team meeting and may lead small operational teams and/or participates in collaborative efforts(Standard Operating Procedure (SOP) development, operational task forces, etc.) • Monitored data— remotely, on site, and via other approved modes — with focus on data integrity and patient safety, in accordance with regulations • Performs study initiation activities with the site personnel, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities • Creates, implements, and maintains systems to track study metrics and general information relating to study execution. Provides updates to the team on metrics as needed. Clinical Research Associate I 03/2014 to 03/2017 PRA Health Science – Providence, RI • Monitors all aspects of assigned Phase 1 and 2 clinical trials to ensure the protection and welfare of subjects, compliance with the protocol, GCP/ICH guidelines, FDA regulations and overall clinical objectives • Manages clinical start-up activities, supply preparation, enrollment, data collection, and close-out • Organizes and perform site qualification, site initiation, interim monitoring and site close-out visits according to PRA Health Science policies and procedures • Writes Site Visit Reports after each visit within the allotted timeframe. • Verifies safety and well being of study subjects were maintained for assigned study sites • Executes clinical trials activities following established SOP, good clinical practices and regulatory requirements