Hybrid Senior Clinical Operations Specialist – FSP

Posted 3 weeks ago

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About the role

  • 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
  • Communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
  • Creates and assists with maintenance of project files
  • Handles project correspondence
  • Participates 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
  • Manages shared mailbox, processes site requests and routes correspondence appropriately
  • Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
  • Attends meetings and prepares accurate meeting minutes and action items
  • Anticipates, identifies and resolves potential issues and implements corrective actions
  • Completes all necessary and assigned training
  • May provide training or mentorship to more junior level Clinical Operations Specialists (COS)

Requirements

  • Experience in Clinical Research with CTA Tasks is a must
  • 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
  • Minimal travel up to 10% may be required

Benefits

  • Career development and progression
  • Supportive and engaged line management
  • Technical and therapeutic area training
  • Peer recognition
  • Total rewards program

Job title

Senior Clinical Operations Specialist – FSP

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Associate's Degree

Location requirements

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