Clinical Operations Specialist at Syneos Health managing site compliance and documentation for biopharmaceutical studies. Collaborating with team members and clients to ensure operational success.
Responsibilities
Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies
Assists Clinical Monitoring staff with site management activities
Communicating with sites to ensure compliance with protocol requirements
Creates and assists with maintenance of project files
Participates in file audits
Prepares and maintains site manuals, reference tools and other documents
Tracks incoming and outgoing clinical and regulatory documents
Manages shared mailbox, processes site requests
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
Anticipates, identifies and resolves potential issues
Completes all necessary and assigned training
Requirements
Associates degree preferred or equivalent
Experience in clinical research/pharma/biotech or related field considered
Good knowledge of medical terminology, clinical data, and ICH/GCP preferred
Ability to successfully prioritize and work on multiple tasks
Strong attention to detail, accuracy and organizational skills
Excellent communication, presentation, and interpersonal skills
Ability to embrace new technologies
Benefits
health insurance
retirement plans
paid time off
flexible work arrangements
professional development
total rewards program
Job title
Senior Clinical Operations Specialist – Local, Global Activities, SSU Tasks
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