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, Non-Oncology – Southeast Hybrid

Monitor Southeast clinical trial sites for Fortrea’s non-oncology research programs. Support participant safety, regulatory compliance, data quality, and adverse-event reporting.

Descriere

  • Deliver high-quality participant care during clinical trials and respond to emergencies in line with research standards.
  • Conduct routine monitoring and close-out visits at clinical sites.
  • Maintain study documentation and lead pre-study and site initiation visits.
  • Coordinate with vendors and complete additional assigned responsibilities.
  • Oversee study sites in accordance with project plans.
  • Provide study staff with the materials and guidance needed for safe patient enrollment.
  • Confirm that informed consent and protocol procedures meet applicable regulations.
  • Protect data integrity by reviewing source documents against Case Report Forms and other collection tools.
  • Identify missing, inconsistent, or implausible study data.
  • Manage registries according to project plans and conduct feasibility activities as requested.
  • Prepare and complete Serious Adverse Event reports, narratives, follow-up, and related documentation.
  • Review CRFs and generate and resolve queries in Fortrea or client data management systems.
  • Support onboarding and development of new employees through activities such as co-monitoring.
  • Coordinate assigned clinical projects as Local Project Coordinator and serve as a local client contact when designated.
  • Complete other responsibilities assigned by management.
  • Travel frequently to client and site locations, including occasional domestic and international trips.

Cerințe

  • A degree from a university or college, or certification in a related allied health profession from an appropriately accredited institution, such as nursing licensure.
  • At least two years of clinical monitoring experience.
  • Willingness to travel overnight approximately 60% of the time.
  • Ability to work in a fast-paced, protocol-driven environment where deviations are not permitted.
  • Ability to manage shifting priorities and adapt quickly.
  • Strong teamwork and interpersonal skills.
  • Ability to work with technology-based systems and enter data electronically.
  • Ability to sit for extended periods and operate a vehicle safely.
  • Ability to perform repetitive movements with both hands, including rapid, simple movements of the fingers, hands, and wrists.
  • Ability to occasionally crouch and stoop, and frequently bend and twist the upper body and neck.
  • Ability to access and use various in-house and commercial computer applications.
  • Ability to lift and carry light to moderate loads, including luggage and a laptop, weighing up to 15–20 pounds.
  • Reliable and consistent attendance.
  • Availability to work varied hours when required.

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