TFS HealthScience - Contract Research Organization
TFS HealthScience - Contract Research Organization
TFS HealthScience - Contract Research Organization yra pasaulinė sutartinių klinikinių tyrimų organizacija, teikianti paramą biotechnologijų ir farmacijos įmonėms viso klinikinio kūrimo proceso metu. Jos paslaugos apima I–III fazės tyrimus, IV fazės realaus pasaulio duomenų tyrimus ir strateginį išteklių telkimą. Organizacija turi dermatologijos, vidaus ligų, neuromokslų, onkologijos ir hematologijos, oftalmologijos, pediatrijos, retųjų ligų bei retųjų vaistų sričių kompetencijos. Įmonė derina visos apimties CRO galimybes ir tarptautinį mastą su vidutinio dydžio organizacijos lankstumu bei individualiu bendradarbiavimu.

Senior Clinical Research Associate, Oncology (Contract, Italy Remote)

Home-based Senior Clinical Research Associate role supporting oncology trials for TFS HealthScience. Responsibilities include site monitoring, compliance oversight, documentation, reporting, and trial-system updates.

Aprašymas

  • Serve as an operational member of the project team
  • Open, monitor both on-site and remotely, and close clinical trial sites
  • Conduct trial monitoring in line with company and sponsor SOPs, GCP, ICH guidelines, and applicable regulations
  • Carry out monitoring activities that protect subject safety and support data integrity and study quality
  • Confirm proper informed consent processes and adherence to study protocols
  • Assess electronic and paper CRFs and source records for accuracy and validity
  • Check investigational product management and accountability
  • Prepare Monitoring Visit Reports, record findings and corrective or preventive actions, maintain tracking systems, and escalate concerns
  • Communicate identified issues and required follow-up actions to study sites
  • Submit site documentation to the eTMF or paper TMF and confirm Investigator Site File upkeep
  • Support preparation for audits and inspections and complete related follow-up
  • Order, ship, and reconcile clinical investigation supplies when required
  • Maintain accurate site information in CTMS and other project systems

Reikalavimai

  • Bachelor’s degree in life sciences or nursing preferred, or an equivalent qualification
  • At least three years of clinical trial monitoring experience in oncology, including at least one Phase I or Phase II study
  • Working knowledge of medical terminology and the science relevant to assigned drugs and therapeutic areas
  • Knowledge of Good Clinical Practice regulations and ICH guidelines
  • Capacity to work independently within a matrixed team environment
  • Strong written and spoken communication skills
  • Fluency in English
  • Highly organized approach to work
  • Confidence with technology, software, and computer applications
  • Willingness and ability to travel up to 60–80%, including overnight and international travel where applicable

Privalumai

  • Competitive compensation package
  • Comprehensive benefits offering
  • Opportunities for personal and professional development
  • Lunch vouchers
  • Health insurance
  • Pension plan
  • Car allowance where applicable
  • Collaborative, innovative working environment

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