Fortrea
Fortrea
Fortrea — биофармацевтикалық және медициналық технология компанияларына қызмет көрсететін жаһандық клиникалық зерттеу ұйымы. Оның клиникалық әзірлеу қызметтері клиникалық фармакологияны, I–IV фазалардағы зерттеулерді басқаруды, реттеуші стратегияны және нарыққа қолжетімділікті қамтып, ғылыми сараптаманы деректерге негізделген тәсілдермен ұштастырады. Fortrea жасушалық және гендік терапия, онкология, жүрек-қантамыр аурулары және жұқпалы ауруларды қоса алғанда, әртүрлі бағыттардағы бағдарламаларды қолдайды. Осы арқылы компания клиенттеріне әзірлеуге қатысты негізделген шешімдер қабылдауға және ықтимал емдеу әдістерін пациенттерге жеткізу үдерісін ілгерілетуге көмектеседі.

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.

Сипаттама

  • 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.

Талаптар

  • 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.

Артықшылықтар

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

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