CRA Manager responsible for oversight, coaching, and performance management of CRA teams to meet clinical trial KPIs. Focused on delivery, quality, and compliance for clinical research in China.
About the role
- Clinical Operations Specialist at Syneos Health supporting compliance and operational activities in clinical research. Collaborating with teams to maintain clinical tracking databases and project files while performing site management roles.
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
Requirements
- High School diploma or equivalent
- Good communication and interpersonal skills
- Ability to embrace new technologies
- Minimal travel up to 25% may be required
Benefits
- Health insurance
- Professional development opportunities
- Flexible working arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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