Clinical Operations Specialist managing site compliance and supporting clinical monitoring in a highly integrated biopharmaceutical organization. Collaborating with teams in clinical development while ensuring accurate clinical tracking.
Responsibilities
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
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