Clinical Operations Specialist
hace 7 días
About the Role
We are seeking a highly skilled Clinical Operations Specialist to join our team at Syneos Health Clinical. As a key member of our Clinical Development team, you will be responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions.
Key Responsibilities
- 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).
Requirements
- Associate degree preferred or equivalent, or 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, and ability to embrace new technologies.
- Minimal travel up to 10% may be required.
About Syneos Health Clinical
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. We are passionate about developing our people, through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
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