Clinical Trial Associate

About the role

The Clinical Trial Associate (CTA) will perform activities related to the planning, execution, and delivery of single and multi-site clinical trials in ProSciento’s CRO division, under the direction of the Clinical Team Manager (CTM) and the Study Startup Manager (SSUM). The CTA will also function as a subject matter expert for the electronic Trial Master File (eTMF) and Clinical Trial Management (CTMS) system. This position will require an understanding of the basic skills necessary for the application of regulatory requirements, ICH/GCP guidelines, and CRO level methodologies. The CTA performs duties in accordance with company’s values, policies, and procedures.

Responsibilities

• Manages the CDA execution process with sites and coordinate the Feasibility Questionnaire process
• Assists with the selection of investigators
• Provides study-specific details for the CTMS system set-up
• Delivers Regulatory Packet and trial-specific documentation
• Collects site essential documents for activation
• Compiles the package of documents for IEC/IRB and forwards to either the investigator or IEC/IRB as directed (throughout the entire study)
• Performs the first review of the Essential Document Packet and completes the SIV Authorization Form
• Populates and updates the Contact List in CTMS
• Prepares and ships Regulatory Binders to sites
• Coordinate initial shipment of lab kits, IP, and supplies to sites
• Ensures all documents for eTMF upload are in correct location, named and labeled appropriately upon site activation
• Participates in the SSU-to-Clinical Operations handover process
• Responsible for collection of site