Note: The job is a remote job and is open to candidates in USA. Syneos Health is hiring a Senior Clinical Operations Specialist to support clinical research studies and site management activities. The role maintains study documentation and tracking systems, coordinates site communications and supplies, and helps ensure compliance with protocols and applicable procedures.
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 project files, handles project correspondence
- Participates 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
- Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues
- Maintains 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)
Skills
- Experience in clinical research/pharma/biotech or related field considered In lieu of degree
- 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
- Associates degree preferred or equivalent
- Good knowledge of medical terminology, clinical data, and ICH/GCP preferred
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture where you can authentically be yourself
Company Overview
Company H1B Sponsorship