Clinical Operations Specialist: Site & Trial Coordination

Syneos Health, Inc.; United States; On-site; USD 60,000 - 85,000; Full time

Job summary

Syneos Health is a leading life sciences services organization providing integrated solutions to accelerate drug development and commercialization. The Clin ops epecialist will support site management, TMF maintenance, and regulatory documentation across assigned studies.

Responsibilities include coordinating with monitoring staff, maintaining tracking databases, and ensuring compliance with SOPs and guidelines.

Qualifications

• High School diploma or equivalent.
• Good communication and interpersonal skills.
• Ability to embrace new technologies.
• Minimal travel up to 25% may be required.

Responsibilities

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.
• Assists 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.
• Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits.
• Prepares and maintains site manuals, reference tools and other documents.
• Maintains, updates, and inputs clinical tracking information into databases.
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
• Manages shared mailbox, processes site requests and routes correspondence appropriately.
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials.
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items.
• May handle receipt, tracking and disposition of Case Report Forms and Queries.
• Maintains overall awareness in the field of clinical research by completing all necessary and assigned training.

Skills

Good communication

Interpersonal skills

Technology adoption

Travel readiness

Education

High School diploma or equivalent

Job description

Syneos Health is a leading life sciences services organization providing integrated solutions to accelerate drug development and commercialization. The Clin ops epecialist will support site management, TMF maintenance, and regulatory documentation across assigned studies.

Responsibilities include coordinating with monitoring staff, maintaining tracking databases, and ensuring compliance with SOPs and guidelines.