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 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 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
Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues
Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.
May provide training or mentorship to more junior level Clinical Operations Specialists (COS).
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
Minimal travel up to 10% may be required
Benefits
Health insurance
Retirement plans
Paid time off
Flexible working arrangements
Professional development opportunities
Applicant Tracking System Keywords
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