Fortrea
Fortrea
Fortrea este o organizație globală de cercetare clinică ce oferă servicii companiilor biofarmaceutice și de tehnologie medicală. Serviciile sale de dezvoltare clinică includ farmacologia clinică, gestionarea studiilor din faza I până în faza IV, strategia de reglementare și accesul pe piață, combinând expertiza științifică cu abordări bazate pe date. Fortrea sprijină programe în domenii precum terapiile celulare și genice, oncologia, bolile cardiovasculare și bolile infecțioase, ajutând clienții să ia decizii informate privind dezvoltarea și să avanseze tratamente potențiale către pacienți.

Clinical Research Associate II, Oncology – Hybrid

Monitor Fortrea’s East Coast oncology clinical trials through site visits, protocol oversight, and participant safety support. Maintain reliable clinical data and study documentation while coordinating site activities and required reporting.

Descriere

  • Support the safe care of clinical trial participants and respond to emergencies in line with clinical research standards
  • Perform routine site monitoring and clinical site close-out activities
  • Maintain study files and conduct pre-study and site initiation visits
  • Coordinate with study vendors
  • Manage assigned study sites in accordance with project plans
  • Provide study staff with the materials and instructions needed for safe patient enrollment
  • Confirm that informed consent processes and protocol requirements meet applicable regulations
  • Protect the accuracy and integrity of Case Report Forms and other data collection tools
  • Review source data for omissions or implausible entries
  • Manage registries and support feasibility activities as requested
  • Complete Serious Adverse Event reports, narratives, and follow-up activities
  • Review CRFs and create and resolve queries in Fortrea or client data management systems
  • Support new-employee training through co-monitoring
  • Coordinate designated clinical projects as a Local Project Coordinator under supervision when applicable
  • Serve as a local client contact when assigned
  • Carry out additional responsibilities assigned by management

Cerințe

  • Degree from an accredited university or college, or certification in a related allied health profession such as nursing licensure
  • At least two years of clinical monitoring experience
  • Experience in oncology
  • Willingness and ability to travel overnight 60% of the time
  • Ability to perform effectively in a fast-changing environment
  • Strong teamwork and interpersonal skills
  • Comfort working with technology-based electronic data systems
  • Ability to sit for extended periods and operate a vehicle safely
  • Ability to perform repetitive hand, finger, and wrist movements quickly and repeatedly
  • Ability to occasionally crouch and stoop and frequently bend and twist the upper body and neck
  • Proficiency with a range of computer software
  • Ability to lift and carry 15–20 pounds
  • Reliable and consistent attendance
  • Availability to work varying hours

Beneficii

  • Remote work arrangement
  • Approximately 60% overnight travel
  • Applications accepted on an ongoing basis

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