Clinical Operations Specialist – Pool
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Job Description
Clinical Operations Specialist managing key operational activities across clinical trial lifecycle at Vanguard Clinical, Inc. Supporting study execution with a focus on data management, vendor oversight, and site support.
Responsibilities:
- The Clinical Operations Specialist (COS) is an experienced, cross-functional clinical research professional responsible for supporting and driving key operational activities across Clinical Operations, Study Start-Up (SSU), Trial Master File (TMF) Management, Data Management, Vendor Oversight, Site Support, and broader study execution.
- Lead administrative and operational coordination across the clinical trial lifecycle.
- Independently manage study trackers, site updates, enrollment metrics, and operational reporting.
- Prepare agendas, lead or co-lead portions of meetings, and finalize high-quality minutes and action items.
- Coordinate cross-functional workflows with CRAs, PMs, Data Management, SSU, Safety, and TMF teams.
- Provide proactive solutions and anticipatory support to internal teams and Sponsor clients.
- Independently manage essential document collection, QC, and readiness for site activation.
- Conduct feasibility outreach, site qualification support, and site-level intelligence collection.
- Lead start-up timeline tracking and drive accountability with sites and vendors.
- Perform advanced QC review for TMF documents and root-cause identification for recurring issues.
- Independently manage TMF filing, metadata application, and cross-checking for document dependencies.
- Support audit/inspection readiness, including TMF remediation, reporting, and corrective action follow-up.
- Perform high-level clinical data review in EDC systems; generate and track complex queries.
Requirements:
- Minimum 3 years of clinical research industry experience, preferably within a CRO, sponsor, or academic research setting
- Proficiency with clinical systems such as eTMF, EDC, CTMS, IWRS, or study tracking tools
- Strong working understanding of ICH-GCP, GDP, and clinical research processes across start-up to close-out
- Demonstrated ability to independently manage multiple tasks and deadlines with minimal supervision
- Flexibility and adaptability to support diverse client needs
- Strong customer service mindset with a solutions-oriented approach
- Demonstrated strengths in planning, organization, time management, problem solving, and attention to detail
- Excellent oral and written communications and presentation skills; ability to communicate effectively with vendors and clients
- Detailed knowledge of Microsoft Office suite of software programs.
Benefits:
- health insurance
- 401k retirement plan
- paid days off
- annual performance bonus
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