Clinical Operations Specialist with Regulatory Compliance Expertise
hace 4 días
About Syneos Health Clinical
We are a leading biopharmaceutical solutions organization, accelerating customer success through innovative clinical, medical affairs, and commercial strategies.
Job Summary:
This role provides critical support to our Clinical Operations team, ensuring the successful completion of project deliverables. The ideal candidate will possess excellent communication skills, attention to detail, and the ability to work effectively in a fast-paced environment.
Key Responsibilities:
- Provide clerical, technical, and administrative support to business units or clients within Clinical Operations;
- Assist Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies;
- Create and maintain project files, handle project correspondence, and participate in file audits;
- 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 the ordering, packaging, shipping, and tracking of site supplies and materials;
- Assist with coordination of team meetings, attend meetings, and prepare accurate meeting minutes and action items;
- Routinely anticipate, identify, and resolve potential issues and implement corrective actions;
- Maintain overall awareness in the field of clinical research and assigned areas by completing necessary training;
- May provide training or mentorship to more junior level Clinical Operations Specialists.
Requirements:
- Associate degree preferred or equivalent experience in clinical research/pharma/biotech or related field;
- 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.
Estimated Salary: $65,000 - $85,000 per year, depending on location and experience. We offer a comprehensive compensation package, including competitive salary, benefits, and opportunities for career growth and development.
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