Clinical Trial Coordinator – Single Sponsor

• Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assist Clinical Monitoring staff with site management activities and serve as a Sponsor representative for assigned study sites
• Communicate with sites to ensure compliance with protocol requirements, study procedures, and relevant guidelines
• Create and maintain project files and handle project correspondence
• Participate in file audits
• Prepare and maintain site manuals, reference tools, and other documents
• Maintain, update, and input clinical tracking information into databases
• Track incoming and outgoing clinical and regulatory documents and updates
• Manage shared mailbox, process site requests, and route correspondence appropriately
• Coordinate ordering, packaging, shipping, and tracking of site supplies and materials
• Assist with team meeting coordination, attend meetings, and prepare meeting minutes and action items
• Anticipate, identify, and resolve potential issues; implement corrective actions
• Complete required clinical research training
• May provide training or mentorship to more junior Clinical Operations Specialists

• Associates degree preferred or equivalent
• Experience in clinical research/pharma/biotech or related field considered In lieu of degree
• 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

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Total Self culture
• Diversity, inclusion, and belonging initiatives