Clin Ops Specialist, CTA

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

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Logo of Syneos Health

Syneos Health

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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 and serve as a Sponsor representative for assigned study sites • 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 participating 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 teams, or clients • Manage shared mailbox, process site requests, and route correspondence appropriately • Coordinate ordering, packaging, shipping, and tracking of site supplies and materials • Assist with team meeting coordination, attend meetings, and prepare accurate minutes and action items • Handle receipt, tracking, and disposition of Case Report Forms and Queries when required • Maintain awareness of clinical research through necessary and assigned training

🎯 Requirements

• High School diploma or equivalent • Good communication and interpersonal skills • Ability to embrace new technologies • Minimal travel up to 25% may be required • Activities must comply with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Reasonable accommodations, when appropriate, for employees or applicants with disabilities

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