Clinical Trial Coordinator
Clinical Trial Coordinator - Fern Valley Consultant Diegem
Since March 2013
- Provide general support to the project teams which includes logging, tracking, and filing of regulatory documents and study paperwork
- Maintaining and tracking of contracts and invoices with study sites and outside vendors
- Create study materials
- Create spreadsheets and track project metrics. Maintain information in study department databases (CTMS)
- Coordination of document collection in the team and with CRO’s - document review
- Contact with site hospital administrative assistants and study nurses
- Support task coordination of Project Leader and support management in the departmental activities. (e.g. coordination between CRAs to meet the required timelines for certain tasks)
- Support in preparation EC/ CA submission packages
- Coordination and documentation of safety reporting
- Provide monthly reports to managers, providing back-up to CRA’s as needed in maintaining up-to-date information on clinical study activity
- Assist CRAs in tracking outstanding (electronic) case report forms and related queries
- Therapeutic areas: arrhythmia, atrial fibrillation
Clinical Safety Officer Assistant via Valesta
April 2010 --- March 2013
- Reporting and tracking of Serious Adverse Events in the scope of clinical trials; - Submission of safety reports to investigators/ ethics committees/ health authorities.
Clinical Project Assistant via Valesta
March 2012 --- November 2012
- Providing administrative and logistical support to the clinical project team; - Coordination, tracking and archiving of study documentation.
Pharmacovigilance Assistant via Valesta
September 2008 --- April 2010
- Collection, reporting and tracking of Adverse Events; - Submission of safety reports to investigators/ ethics committees/ health authorities.
Assistant, Drug Supplies, Labeling and Site Documentation – Regulatory Affairs and Quality Assurance
October 2007 --- September 2008
- Review and approval of regulatory documentation; - Logistical support of clinical trial supply coordination.
Data Coordinator – Investigator Services
March 2006 --- October 2007
- Input of demographic data and correction of inadequacies; - Exchange of information between the sites, monitors, sponsors and the laboratory.
Anger commandImpulse commandPerspectiveOrganization
OptimismSociabilityInterest in knowledgeWillingness to compromiseAttention to detail
Principles and ethics of clinical researchscienceLife SciencesMultilingualPhases of clinical development (phase I to IV)ProtocolProject ManagementTeamwork
Cardiovascular diseasesEndocrinology and metabolismPhases of clinical development (phase I to IV)Clinical trial designRandomization and blindingDrug development processICH GCP guidelinesInformed Consent ProcessClinical researchElectronic Data Capture (EDC) EnglishClinical trialsMedical DevicesCTMS
Skills and Expertise
Identify and provide training to trial team and associated staffCreates a collaborative team environmentWork collaboratively with the other members of the clinical research team Act as the main line of communication between the sponsor and the investigatorCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Calculate timelines for conducting and completing the trialCoach and provide guidance to clinical staff.
Answer, transfer and handle incoming calls as needed.Perform administrative support duties as requiredperform data entryPlan work to meet objectives and deadlinesprepare study-related documentation; Provide general office management to keep operations running smoothly.Submit regulatory applicationsUpdate Clinical Trials Management System (CTMS) Archive trial documentation and correspondence.Assemble regulatory applicationsWork collaboratively with the other members of the clinical research team
postgraduate in Diabeteseducator from Artevelde Hogeschool Gent in 2006
Bachelor in Nutrition and Dietetics from Plantijnhogeschool van de provincie Antwerpen in 2005
in from Lessius Hogeschool Antwerpen in 0