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Jana Levans

Jana Levans

Clinical Research Associate II | Site Enrollment, Engagement & Study Training | Czech Republic

Vienna, WienMitglied seit 8. November 2025
Site engagementSite-level clinical trial experienceInternal reportingProtocol complianceSubject visit readinessQuery managementSDV/SDRData qualitySite payment operationsFinancial planningBudget-related reportingAE/SAE documentationMonitoring reports
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Über

Clinical research professional with CRA and site-level clinical trial experience across Phase II-IV studies, with strong focus on site engagement, patient recruitment support, procedural training, site communication and study delivery. Experienced in developing site-specific follow-up plans, educating healthcare professionals and site staff on protocols and study procedures, supporting pre-screening, screening and enrollment activities, maintaining study records and trackers, and completing internal reporting. Strong interpersonal and written communication skills, customer-service orientation, cultural awareness and collaborative approach.

Fluent in Czech, English and Slovak, with flexibility to travel and experience working across multiple therapeutic areas.

Berufserfahrung

Clinical Research Associate II - Fortrea (Formerly Labcorp) - Prague, Czech Republic

(2026-04)

  • Manage and support research sites through routine monitoring, initiation, validation and close-out activities, with focus on protocol compliance and site readiness.
  • Develop and follow up on site-specific action items to support study conduct, subject screening, enrollment activities and timely resolution of site barriers.
  • Educate investigators, healthcare professionals and study staff on protocol requirements, informed consent process, safety reporting, study procedures and system use.
  • Partner with site teams, vendors, sponsors and internal project teams to address operational challenges, manage objections and maintain positive working relationships.
  • Review subject-level and site-level documentation, pre-screening and screening information, visit readiness, training documentation and monitoring findings.
  • Maintain trackers, CTMS/XRIM documentation, monitoring reports and action logs to support internal reporting and continuous follow-up.
  • Support site training and re-training after new protocol versions, informed consent updates, laboratory process changes and system/document releases.

Clinical Research Associate II - Syneos Health s.r.o. - Prague, Czech Republic

(2025-01 - 2026-03)

  • Oversaw and coordinated site activities in pediatric diabetology, neurology, nephrology and pulmonary clinical trials in Phase II / III.
  • Delivered protocol and procedure-related guidance to site teams and supported implementation of study-specific requirements during SIV, monitoring and close-out activities.
  • Worked closely with investigators and site staff to support subject enrollment, query resolution, AE/SAE documentation and overall study delivery.
  • Maintained regular communication with sponsors, project teams, vendors and research sites to resolve issues and support timely completion of required actions.
  • Prepared monitoring reports, tracked open actions and supported inspection-ready documentation in alignment with ICH-GCP and sponsor standards.

Clinical Research Associate I - IQVIA s.r.o. - Prague, Czech Republic

(2022-05 - 2024-12)

  • Monitored research sites including SIV, SMV and close-out visits across Neurology, Pulmonary and Cardiology therapeutic areas - Phases II-IV.
  • Supported site-level study delivery through investigator/site communication, action tracking, document review, EC submissions and escalation of open items.
  • Maintained study records, clinical trackers and site documentation to support enrollment oversight, reporting and sponsor requirements.
  • Collaborated with site teams to support protocol compliance, subject visit readiness, query management, SDV/SDR and data quality.
  • Oversaw site payment operations, financial planning and budget-related reporting while maintaining customer-focused communication with sites and sponsors.

Ausbildung

Bachelor's degree - UCL

Diploma certificate - Higher Medical School

GCSE - Business and Management - České Budějovice, Czech Republic

Fähigkeiten

Clinical Research Associate IISite EnrollmentEngagement & Study TrainingCzech Republic

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