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Clin Ops Specialist, CTA
Syneos Health. Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates strong compliance with Corporate and Clinical Operations Policies and Standard Operating Procedures while effectively managing clinical trial documentation and communication with study sites. Proficient in maintaining clinical tracking information and coordinating site management activities.
Highest-signal resume keywords
Clinical Operations ComplianceTrial Master File ManagementClinical Tracking Information MaintenanceSite Management CoordinationEffective Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial DocumentationDatabase ManagementFile AuditingCase Report Form HandlingRegulatory Document Tracking
Soft Skills
Interpersonal SkillsCommunication SkillsTeam Coordination
Industry Keywords
Clinical ResearchStandard Operating ProceduresWork InstructionsSite ManagementProtocol Compliance
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 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
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
- 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
Comp & perks- 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