Clinical Operations Specialist
hace 2 meses
Job Summary
As a Clinical Operations Specialist at Syneos Health, you will play a critical role in ensuring the success of our clinical trials. Your responsibilities will include performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. You will assist 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.
Key Responsibilities
- Assist with site management activities, including serving as a Sponsor representative for sites on assigned studies.
- Communicate with sites to ensure compliance with protocol requirements, study procedures, and relevant guidelines.
- Create and maintain Trial Master File (TMF) and project files, including participation 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 for investigator sites, studies, project team, or client.
- 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.
- May handle receipt, tracking, and disposition of Case Report Forms and Queries.
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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