Enthusiastic and accomplished Clinical Project coordinator with a passion for Clinical Research and Pharmaceutical sciences seeking admission in process validation and regulatory affairs program at Technological University of the Shannon. Eager to leverage my background and participate in the academic community and further develop expertise in regulatory affairs and process validation.
- Study set up: Uploading details of participating project sites in LIMS database, process portal access, process import permit and coordinate with courier to provide pick-up details etc, to the participating sites.
-Conduct phase: Monitoring on-time release of patient laboratory report including safety and alert reports. Performing monitoring activities for mega trials which includes but is not limited to: monitoring the day to day running of designated projects, including overview of specimen management receipt, lab analyses, and other scope of activities as detailed in the project monitoring plan
-Closeout phase: Resolve all outstanding issues, send out closeout memos to sites, prepare and submit closeout checklist. Participate in data reconciliation as well.
Project Management
Good Clinical Practise certification from National Institute on Drug Abuse (NIDA)