ICON plc sog‘liqni saqlash va farmatsevtika sohalariga xizmat ko‘rsatuvchi global shartnoma asosidagi tadqiqot tashkilotidir. Kompaniya faoliyati dastlabki tadqiqotlardan tortib, marketingdan keyingi jarayonlargacha dori vositalarini ishlab chiqishni qo‘llab-quvvatlovchi klinik, konsalting va tijoriy xizmatlarni qamrab oladi. ICON plc markazlashtirilmagan klinik sinovlar, yurak xavfsizligi, dastlabki klinik laboratoriyalar, tibbiy tasvirlash, tartibga solish bo‘yicha ma’lumotlar va real hayot ma’lumotlari kabi yechimlarni taqdim etadi. Shuningdek, kompaniya yurak-qon tomir kasalliklari, onkologiya, ichki kasalliklar, hujayra va gen terapiyalari hamda biosimilyarlar kabi yo‘nalishlarda terapevtik tajribaga ega bo‘lib, klinik dasturlarni rivojlantirishga yordam berish uchun ma’lumotlar tahlilini bemorga yo‘naltirilgan yondashuvlar bilan birlashtiradi.
Senior Clinical Research Associate, Oncology — ICON plc (Remote, Pennsylvania)
Senior Clinical Research Associate supporting sponsor-dedicated oncology trials for ICON plc. The role oversees site monitoring, regulatory compliance, data quality, and resolution of clinical trial issues.
Tavsif
- Conduct and monitor clinical trials to confirm sponsor and investigator responsibilities meet applicable regulations and ICH Good Clinical Practice (GCP) standards.
- Evaluate prospective investigative sites, initiate studies, train site staff, and complete site closeout activities.
- Manage site startup tasks, including regulatory document collection, informed consent review, IRB/IEC submission support, and budget and contract negotiations.
- Review clinical trial data collected onsite or remotely and verify its accuracy.
- Report site status to clinical team members and trial management, while maintaining trial management tools.
- Complete monitoring documentation in accordance with sponsor standard operating procedures.
- Collaborate with clinical team members to address trial and clinical issues.
- Escalate site and trial concerns through resolution or formal closure.
- Reconcile essential documents in site files, perform source document verification, and resolve data queries.
- Evaluate investigational product accountability, dispensing, and compliance.
- Verify serious adverse event reporting against trial requirements and ICH GCP guidelines.
- Communicate with investigative sites and maintain relevant tracking systems.
- Confirm that required training is completed and documented.
- Work independently at the senior level and contribute subject matter expertise when appropriate.
- Support complex studies and sites as assigned.
- Lead designated clinical operations projects.
- Serve as the leader for observation and performance visits.
- Coordinate with other functional areas to resolve site issues and support trial timelines.
Talablar
- Bachelor’s degree or equivalent in a clinical, scientific, or health-related discipline from an accredited institution; a licensed healthcare professional, such as a registered nurse, or equivalent work experience is also accepted.
- Two to five years of clinical monitoring experience for CRA 2 roles.
- More than five years of clinical monitoring experience for Senior CRA roles.
- Understanding of ICH requirements and local regulatory authority regulations for drug studies.
- Fluent written and spoken English.
- Previous oncology monitoring experience.
- Experience with feasibility assessments, site selection, and site startup.
- Budget negotiation experience is preferred.
- Applicants must be legally authorized to work in the United States and must not require current or future employment visa sponsorship.
- Employment with ICON requires the legal right to work in the country where the role is based.
Imtiyozlar
- Competitive base pay with performance-related incentives.
- Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life insurance and disability coverage.
- Employee assistance programs and wellbeing resources.
- Structured training and career development opportunities.