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Clinical Operations Specialist
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 communication and interpersonal skills while ensuring compliance with clinical research protocols and operational policies. Proficient in managing clinical documentation and tracking information to support site management activities.
Highest-signal resume keywords
Clinical Research ComplianceTrial Master File ManagementDocument Tracking and ManagementCommunication with Investigator SitesSite Management Coordination
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 TrackingDocument ManagementFile AuditsSite Manual PreparationCase Report Form Handling
Soft Skills
Good Communication SkillsInterpersonal SkillsAdaptability to New Technologies
Tools & Technologies
Clinical DatabasesShared Mailbox Management
Industry Keywords
Clinical Operations PoliciesStandard Operating ProceduresWork InstructionsProtocol RequirementsStudy Procedures
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, including serving 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, including participation 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 team, or client
- Manage shared mailbox, process site requests and route correspondence appropriately
- Coordinate ordering, packaging, shipping and tracking of site supplies and materials
- Assist with coordination of team meetings, attend meetings and prepare accurate meeting minutes and action items
- Handle receipt, tracking and disposition of Case Report Forms and Queries when required
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
- Maintains overall awareness in the field of clinical research by completing all necessary and assigned training
- 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
- Total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate, for employees or applicants with disabilities