Clinical Operations Specialist
hace 1 semana
Syneos Health Clinical is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage our expertise in clinical development to deliver high-value insights, speed therapies to patients, and provide practical value to our customers.
Job SummaryWe are seeking a highly skilled Clinical Operations Specialist to join our team. As a Clinical Operations Specialist, you will play a critical role in ensuring the success of our clinical trials by providing operational support, managing site relationships, and maintaining accurate records.
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 project files, handle project correspondence, and participate in file audits.
- Prepare and maintain site manuals, reference tools, and other documents, and 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, and manage shared mailbox, process site requests, and route correspondence appropriately.
- Coordinate the ordering, packaging, shipping, and tracking of site supplies and materials, and 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, seeking guidance as needed to resolve more complex issues, and maintain overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.
- May provide training or mentorship to more junior level Clinical Operations Specialists (COS).
- Associate 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.
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