Clinical Operations Specialist

Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Work mode: Minimal travel up to 25% may be required
Contract: Permanent

Job summary:
The position is responsible for providing clerical, administrative, and technical administrative support to one or more business units or clients within Clinical Operations.

Job responsabilities:

• 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.

What we’re looking for:

• High School diploma or equivalent
• Good communication and interpersonal skills
• Ability to embrace new technologies