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