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.

Senior Clinical Research Associate II, Ophthalmology (Remote)

Senior Clinical Research Associate II overseeing ophthalmology clinical trials across the U.S. East Coast for Fortrea. The role covers site monitoring, participant safety, regulatory compliance, and clinical data quality.

Descriere

  • Deliver high-quality participant care during clinical trials and respond to emergencies in line with clinical research standards.
  • Perform routine site monitoring, close-out visits, and other clinical site oversight activities.
  • Maintain study documentation and conduct pre-study and site initiation visits.
  • Coordinate with study vendors.
  • Manage clinical sites in accordance with project plans.
  • Provide study staff with the materials and guidance needed for safe patient enrollment.
  • Confirm that informed consent processes and protocol requirements meet applicable regulations.
  • Protect the integrity of data recorded on Case Report Forms and other collection tools.
  • Review study data for omissions and implausible entries.
  • Manage registries and complete feasibility activities as requested.
  • Prepare and complete Serious Adverse Event reports, narratives, and follow-up.
  • Review CRFs and generate and resolve queries in Fortrea or client data management systems.
  • Support onboarding and development of new employees through co-monitoring.
  • Coordinate assigned clinical projects as the Local Project Coordinator.
  • Serve as a local point of contact for clients when assigned.
  • Carry out additional responsibilities delegated by management.

Cerințe

  • Live on the U.S. East Coast.
  • Hold a degree from an accredited university or college, or certification in a related allied health profession, such as nursing licensure.
  • Bring at least five years of clinical monitoring experience.
  • Oncology experience is preferred, particularly in early-phase studies.
  • Be available for 30–50% overnight travel.
  • Work effectively in a fast-paced, technology-driven environment with shifting priorities.
  • Demonstrate strong teamwork and interpersonal skills.
  • Remain seated for extended periods and operate a vehicle safely.
  • Perform repetitive movements with both hands, including rapid, simple finger, hand, and wrist motions.
  • Occasionally crouch or stoop and frequently bend or twist the upper body and neck.
  • Use a range of computer software applications.
  • Lift and carry light to moderate loads, including luggage and a laptop, weighing up to 15–20 pounds.
  • Maintain regular and reliable attendance.
  • Accommodate varied working hours when required.

Beneficii

  • Remote work arrangement.
  • Applications accepted on an ongoing basis.

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