Bernadette Kooi Email & Phone Number

Morrisville, NC, US

As Project Coordinator, I assist Project Managers in meeting study goals. I do this by assessing and tracking the progress, needs and potential obstacles of each study. I also coordinate the study teams' efforts in meeting deliverables, such as completing study training, study documentation and study timelines. I actively track and project study finances.

North Wales, PA, US

• RESPONSIBILITIES:As ASSISTANT CRA my responsibilities expanded from coordinator and included:
• Implemented assessment components of protocols in collaboration with vendors by developing the processes through which subjects would be evaluated, how assessments were scored and how results were utilized by sites and.
• Developed site response plan for actively suicidal, homicidal or abused/neglected subjects based upon applicable federal and state laws and current standards of care
• Represented the sponsor and presented at Investigator MeetingsAs COORDINATOR I assisted the project managers throughout the life cycles of clinical trials; my responsibilities included:
• Reviewed study budget proposals, work orders/change orders and timelines
• Set up, maintained and participated in the audits of Trial Master Files

Philadelphia, PA, US

• RESPONSIBILITIES:
• Oversaw daily operations across multiple protocols to ensure not only protocol compliance, but also compliance to local SOPs, FDA guidelines, ICH-GCP and other applicable regulations
• Authored IRB and DSMB submissions
• Coordinated subject visits
• Maintained study data over multiple protocols
• Acquired, processed and shipped subject specimens

Master Of Arts, Political Science And International Relations

Master Of Science, Clinical Health Psychology

Bachelor Of Science, Psychology