Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits
Prepares and maintains site manuals, reference tools and other documents
Maintains, updates, and inputs clinical tracking information into databases
Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
Manages shared mailbox, processes site requests and routes correspondence appropriately
Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
May handle receipt, tracking and disposition of Case Report Forms and Queries
Maintains overall awareness in the field of clinical research by completing all necessary and assigned training

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
We are committed to building an inclusive culture – where you can authentically be yourself

Clinical Operations Specialist – Managed Access Program Admin

Key skills