Clinical Operations Specialist, Sponsor Dedicated

Role Overview

• Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assist Clinical Monitoring staff with site management activities
• Serve as a Sponsor representative for sites on assigned studies
• Communicate with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Create and assist with maintenance of Trial Master File (TMF) and project files
• Participate in file audits
• Prepare and maintain site manuals, reference tools and other documents
• Maintain, update, and input clinical tracking information into databases
• Track incoming and outgoing clinical and regulatory documents
• Manage shared mailbox and process site requests
• Coordinate ordering, packaging, shipping and tracking of site supplies and materials
• Assist with coordination of team meetings and prepare accurate meeting minutes and action items
• Handle receipt, tracking and disposition of Case Report Forms and Queries
• Maintain overall awareness in clinical research by completing related training

Requirements

• High School diploma or equivalent
• Good communication and interpersonal skills
• Ability to embrace new technologies
• Minimal travel up to 25% may be required

Benefits

• We are passionate about developing our people, through career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Committed to building an inclusive culture