Clinical Trials Coordinator

The Clinical Trial Coordinator is responsible for providing operational support for the day-to-day execution of clinical trials. Follows established SOPs, GCP and other applicable regulatory requirements in the execution of all activities. Proactively identifies and resolves/refers operational project issues and participates in process improvement initiatives as required

• Ensures timely and accurate study-related communication to clinical personnel (e.g., internal/external study teams, consultants and investigative site personnel)
• Prepares and disseminates clinical trial correspondence and newsletters and assists with the creation of study-specific manuals, tools, and templates
• Coordinates team meetings for the trial by arranging logistics, preparing necessary materials and recording and distributing minutes
• Establishes, tracks, and maintains audit-ready clinical trial documentation and study status in tracking tools
• Manages and tracks regulatory/IRB/EC/REB documentation, Confidentiality Disclosure Agreements, and other clinical trial documents
• Ensures necessary study supplies are available as per study timelines (e.g., Case Report Forms, Study Manuals, Lab Kits, etc.
• Manages, reviews and tracks drug shipment, destruction, and return
• Participates in study design and execution by contributing operational experience and expertise as it relates to protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications
• Assists with study or site feasibility process

Qualifications:
• Clinical research knowledge and an understanding of clinical trial methodology
• Strong interpersonal skills and communication skills (written and oral) guided by strict ethics
• High organization abilities, effectively documenting activities and communications
• Ability to work effectively in a team environment

About Biogen Idec: Transforming Discovery into Care
With operations across the Americas, Europe, and Asia, Biogen Idec (NASDAQ:BIIB) is one of the world's leading biotechnology companies, creating new standards of care in oncology, neurology, and immunology. Every day, employees of Biogen Idec make a difference in people's lives, through pioneering research and development, manufacturing, and our worldwide commercial capabilities.

Learn more at www.biogenidec.com/careers.

Biogen Idec is proud to be an equal opportunity employer.

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