In-house Clinical Research Associate
Since October 2015
-Performing investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.
-Utilizing the Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked.
-Performing essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
-Supporting investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
-Performing study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.
-Documenting site and Sponsor contact and study interactions in a timely and professional manner.
-Assisting with resolution of investigational site/data queries.
-Liaising with project team members regarding study site issues.
-Providing quality review of the informed consent template.
-Performing study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study.
-Following up with sites for trial invoices and ensures CTMS is accurately updated to allow the timely processing of Investigator Payments.
-Performing other duties as assigned.
Graduate Student Researcher
February 2015 --- June 2015
Exploratory research into patient participation in clinical trials.
September 2014 --- February 2015
Optimizing Customer Experience.
May 2013 --- June 2013
Assistant pharmaceutical manager
February 2011 --- January 2013
Bachelor of Health in Pharmaceutical Business Administration, Farmakunde from Hogeschool van Utrecht in 2015
HAVO in Natuur & techniek from Pieternieuwlandcollege in 2011
Training and Certification
Bachelor of Health Certification