Clinical Trial Coordinator – Single Sponsor
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Job Description
Clinical Trial Coordinator supporting sponsor sites, documentation, and tracking for Syneos Health’s biopharmaceutical clinical trials. Coordinating regulatory materials, supplies, meetings, and corrective actions.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- 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
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