TFS HealthScience - Contract Research Organization
TFS HealthScience - Contract Research Organization
TFS HealthScience - Contract Research Organization este o organizație globală de cercetare în baza unui contract, care sprijină companiile de biotehnologie și farmaceutice pe parcursul dezvoltării clinice. Serviciile sale includ studii din fazele I–III, studii de fază IV privind dovezile din lumea reală și furnizarea strategică de resurse, cu expertiză în dermatologie, medicină internă, neuroștiință, oncologie și hematologie, oftalmologie, pediatrie, boli rare și medicamente orfane. Compania combină capacitățile și acoperirea internațională ale unei organizații de cercetare clinică cu servicii complete cu flexibilitatea și colaborarea personalizată ale unei organizații de dimensiune medie.

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.

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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

Locuri de muncă similare

GitLab

Director of Analytics Engineering at GitLab (Remote, US)

GitLab

Lead GitLab’s analytics engineering team and shape data strategy for its DevSecOps platform. Build trusted semantic models, AI-enabled data access, BI tools, and company-wide data applications.

Deschide
Medtronic

Customer Service Representative III – Medtronic

Medtronic

Manage customer inquiries, repair requests, quotations, and orders for Medtronic healthcare technology. Coordinate service work with engineers, workshops, vendors, and internal teams.

Deschide
American Electric Power

Senior Enterprise Observability Engineer

American Electric Power

Manage Dynatrace, SolarWinds, and ServiceNow monitoring across American Electric Power’s regulated energy operations. Strengthen visibility across applications, infrastructure, cloud, and networks.

Deschide