Experience

PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Clinical Research Associate 1

  • Sep 2020 - Present

  Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines; Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites; Reviews and verifies accuracy of clinical trial data collected, either onsite or… Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines; Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites; Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely; Provides regular site status information to team members, trial management, and updates trial management tools; Completes monitoring activity documents as required by PRA SOPs or other contractual obligations; Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues ; Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed; Performs essential document site file reconciliation; Performs source document verification and query resolution; Assesses IP accountability, dispensation, and compliance at the investigative sites; Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines; Communicates with investigative sites; Updates applicable tracking systems; Ensures all required training is completed and documented; Serves as observation visit leader; Facilitates audit s and audit resolution. Show more Show less



CPclin - Centro De Pesquisas Clínicas

• Brazil
• Wellness and Fitness Services
• 1 - 100 Employee

• CLINICAL RESEARCH COORDINATOR

  • Jul 2017 - Sep 2020

• JUNIOR CLINICAL RESEARCH COORDINATOR

  • Jul 2015 - Jul 2017

• CLINICAL RESEARCH ASSISTANT

  • Jul 2014 - Jul 2015

• STUDY COORDINATOR TRAINEE

  • Sep 2013 - Jul 2014