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Clinical Operations Specialist

2 months ago

Montreal Quebec, Québec, Canada Syneos Health Full time

Job responsibilities

• 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

Qualifications - What we’re looking for

• High School diploma or equivalent

• Good communication and interpersonal skills

• Ability to embrace new technologies