Bilingual Site Supervisor (English and Spanish)

Johnson County Clintrials LLC
  • Satsuma, TX
    1 day ago

    Job Description

    Bilingual Site Supervisor (English and Spanish) Position Summary: The Site Supervisor is responsible for assuring the study team is accountable for performing assigned responsibilities in compliance with project plans, federal regulations, GCP and good medical practice. This position collaborates and participates with internal teams and external stakeholders to ensure all studies are adequately and appropriately resourced and delivered efficiently to timeline, budget and quality expectations. This position reports directly to the Site Director. Key Responsibilities: Oversees leadership of the Clinical Operations team while ensuring site training/communications are occurring Actively participates in the coordination of clinical trials Ensures study compliance against protocol, SOPs, regulations and ICH/GCP guidelines Acts as a primary liaison with CRO/sponsors; establishes quality guidelines to ensure clinical study vendors are adhering to the agreed upon timelines Build and maintain strong relationships with investigators, referring physicians, and community partners Ensures timely responses from clinical site staff and all regulatory agencies Develop strong, collaborative working relationships with CROs, sponsors, investigators, escalates to Site Director as needed With input from the Site Director, allocates studies across teams Oversees that all study Start-Up activities are in place for any new study prior to consenting participants. Oversees ongoing study progress, data collection, and cleaning activities for all study trials under their purview Prepares reports, drives site to hit KPIs and provides ongoing updates for leadership team/meetings Provides oversight and mentors CRCs on source quality Interviews and onboards new hires Conducts continuing performance management and annual reviews Works with QA to write, resolve and identify all CAPAs Ensure adherence to Good Clinical Practice (GCP), FDA regulations, and IRB requirements Communicates out of scope activities to ensure billing compliance and communicates all study invoiceables timely Ensures staff work is “inspection ready” at all times Represent the site at industry meetings and conferences PI5cb6e6d4e9de-25448-415823905c143e31-5e48-4549-b638-05792d185386

    Numbers & Facts

    LocationSatsuma, TX

    Skills

    • Billingunmatched
    • Budgetingunmatched
    • Clinical Trialunmatched
    • Clinical Trial Managementunmatched
    • Conferencesunmatched
    • Contract Research Organization (CRO)unmatched
    • Data Cleaningunmatched
    • Data Collectionunmatched
    • English Languageunmatched
    • FDA Requirementsunmatched
    • Federal Laws and Regulationsunmatched
    • GCP (Good Clinical Practices)unmatched
    • ICH Regulationsunmatched
    • IRB/IEC (Institutional Review Board/Independent Ethics Committee)unmatched
    • Leadershipunmatched
    • Maintain Complianceunmatched
    • Mentoringunmatched
    • Multilingualunmatched
    • Performance Managementunmatched
    • Performance Metricsunmatched
    • Project Planningunmatched
    • Quality Assuranceunmatched
    • Regulationsunmatched
    • Reporting Skillsunmatched
    • Spanish Languageunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Startupunmatched
    • Team Playerunmatched
    • Time Managementunmatched

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