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Senior Clinical Trials Associate

Trident Consulting

  • Aliso Viejo, CA
  • 17 days ago
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    Skills

    • Adverse Eventsunmatched
    • Analysis Skillsunmatched
    • Clinical Dataunmatched
    • Clinical Trialunmatched
    • Clinical Trial Managementunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Cross-Functionalunmatched
    • Data Analysisunmatched
    • Data Cleaningunmatched
    • Data Qualityunmatched
    • Document Controlunmatched
    • Documentationunmatched
    • External Auditunmatched
    • FDA (Food and Drug Administration)unmatched
    • FDA Requirementsunmatched
    • File Maintenanceunmatched
    • GCP (Good Clinical Practices)unmatched
    • Healthcare Qualityunmatched
    • ICH Regulationsunmatched
    • IP (Internet Protocol)unmatched
    • Intellectual Property (IP)unmatched
    • Internal Auditunmatched
    • Investigational New Drug (IND)unmatched
    • Leadershipunmatched
    • Logisticsunmatched
    • Maintain Complianceunmatched
    • Mentoringunmatched
    • Metricsunmatched
    • Operations Managementunmatched
    • Ophthalmologyunmatched
    • Organizational Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Developmentunmatched
    • Process Improvementunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Risk Analysisunmatched
    • Site Initiationunmatched
    • Startupunmatched

    Description

    Position: Senior Clinical Trials Associate
    Location: Aliso Viejo, CA
    Job Type: Contract (6 Months)

    Position Summary
    We are seeking an experienced Senior Clinical Trials Associate II to support the planning, coordination, and execution of global clinical studies. This role is responsible for managing clinical trial operations, ensuring regulatory compliance, overseeing Study Master File (SMF) activities, supporting site start-up, reviewing clinical data, and driving operational excellence across multiple clinical programs.

    Key Responsibilities
    Clinical Trial Management
    • Coordinate and execute clinical trials across multiple investigative sites.
    • Support protocol development, study documentation, and study execution.
    • Manage site communications and ensure adherence to study timelines.
    • Collaborate with CRAs, investigators, and cross-functional teams.
    Clinical Data & Quality Oversight
    • Review and analyze clinical trial data for accuracy and completeness.
    • Lead data cleaning activities and resolve data discrepancies.
    • Monitor study metrics and identify operational risks.
    • Ensure data integrity and regulatory compliance.
    Study Master File (SMF) & Regulatory Compliance
    • Manage and maintain Study Master Files (SMF/eTMF).
    • Ensure audit readiness and compliance with GCP, FDA, and international regulations.
    • Support regulatory inspections and internal/external audits.
    • Drive document control and process improvements.
    Site Start-Up & Operational Support
    • Coordinate site start-up documentation and regulatory binders.
    • Support Site Initiation Visits (SIVs) and monitoring activities.
    • Track site activation, enrollment, adverse events, and study milestones.
    • Coordinate investigational product (IP) logistics and site support.
    Leadership & Continuous Improvement
    • Lead investigator and cross-functional meetings.
    • Mentor junior Clinical Trial Associates.
    • Support CRA development and co-monitoring activities.
    • Identify process improvements to enhance clinical operations.
    Required Qualifications
    • 8+ years of Clinical Trials Associate (CTA) experience.
    • Experience managing clinical trials from start-up through close-out.
    • Strong knowledge of GCP, FDA, ICH, and international regulatory requirements.
    • Experience with Study Master File (SMF/eTMF) management.
    • Strong clinical data review, data cleaning, and issue resolution experience.
    • Experience supporting audits, inspections, and regulatory compliance.
    • Excellent communication, analytical, and organizational skills.
    Preferred Qualifications
    • Ophthalmology clinical trial experience.
    • Experience mentoring junior CTAs or leading study activities.
    • Experience with investigational product (IP) management.
    • Experience supporting global or multi-site clinical trials.

    Numbers & Facts

    LocationAliso Viejo, CA

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