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Clinical Operations Specialist
hace 2 meses
We are seeking a highly skilled Clinical Operations Specialist to join our team at Syneos Health. As a key member of our clinical development team, you will be responsible for ensuring the smooth execution of clinical trials.
Key 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, 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.
- Create and assist with maintenance of 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.
- Maintain overall awareness in the field of clinical research by completing all necessary and assigned training.
- High School diploma or equivalent.
- Good communication and interpersonal skills.
- Ability to embrace new technologies.
- Minimal travel up to 25% may be required.
Syneos Health is a leading 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. Together, we share insights, use the latest technologies, and apply advanced business practices to speed our customers' delivery of important therapies to patients. We support a diverse, equitable, and inclusive culture.
