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Clinical Operations Specialist, Sponsor Dedicated
Syneos HealthClinical Operations Specialist managing site activities and compliance in a hybrid role at Syneos Health. Collaborating with clinical monitoring staff to uphold standards and improve patient outcomes.
About the role
Key responsibilities & impact- 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
- Serve as a Sponsor representative for sites on assigned studies
- Communicate with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
- Create and assist with maintenance of Trial Master File (TMF) and project files
- Participate 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
- Manage shared mailbox and process site requests
- Coordinate ordering, packaging, shipping and tracking of site supplies and materials
- Assist with coordination of team meetings and prepare accurate meeting minutes and action items
- Handle receipt, tracking and disposition of Case Report Forms and Queries
- Maintain overall awareness in clinical research by completing related training
Requirements
What you’ll need- High School diploma or equivalent
- Good communication and interpersonal skills
- Ability to embrace new technologies
- Minimal travel up to 25% may be required
Benefits
Comp & perks- 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
- Committed to building an inclusive culture
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical TrackingFile AuditsCase Report Form ManagementProtocol ComplianceDocument Preparation
Soft Skills
Interpersonal SkillsCommunication SkillsAdaptability to New Technologies