Clinical Trial Administrator

Coloplast A/S

The Clinical Trial Administrator (CTA) fulfils a specialized research role within the Clinical Research department. The CTA supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of a study. This role is responsible for preparing and maintaining Clinical Trial documentation and supervising administrative activities. In performing these duties, the CTA works closely with Clinical Research Associates to support and provide guidance on the administration of all related aspects of a clinical study.

The Clinical Trial Administrator is based in a Kerecis office and reports to the Director of Clinical Affairs. This is a full-time role.

Major Areas of Accountability

• Assist in the preparation and maintenance of clinical trial documentation
• Submit clinical trials to institutional review boards/ethics committees
• Cooperate with Clinical Trials Monitors
• Participate in Clinical Trials team meetings
• Conduct correspondence and make telephone contact with study sites
• Reporting ongoing progress to project manager(s)
• Maintain and report identified metrics
• Prepare other study materials, including but not limited to enrollment logs, drug/device accountability logs
• Prepare applicable submission forms and submit updated documents
• Establish and organize study files, including but not limited to study-specific source documentation, regulatory binders and other materials
• Assist principal investigator/site in communication
• Weekly phone calls to each study center to aid shipment of product and other study materials
• Document status of each center’s recruitment, number of screened patients, enrolled patients, and their current week status, dropouts, and patients that have completed the study; all study documents should be uploaded and organized appropriately in SharePoint
• Prepare monthly status updates on study progress for meetings and the Clinical Newsletter
• Prepare agendas and take notes for all Clinical Development team meetings (Project Check-in, Trial Council, Monthly Presentations, etc.)
• Serve as Administrative Secretary of Trial Council
• Submit and process all vendor/site/contractor invoices in a timely manner upon receipt and follow up with Finance and Accounting until approved. Ensure Net 30 payment terms are adhered to
• Submit required POs for study center recruitment and materials for the trial
• Compile study binders for sites and ship them to sites as needed
• Track documentation required for each center and file them appropriately
• Label study material appropriately with designated stickers and Serial Numbers, as needed, to prepare for shipment to sites
• Request Kerecis and control material for study and facilitate shipment of study materials to sites
• Anticipated travel