ICON plc je globalna pogodbena raziskovalna organizacija, ki zagotavlja storitve za zdravstveno in farmacevtsko industrijo. Njeno delo vključuje klinične, svetovalne in komercialne storitve, ki podpirajo razvoj zdravil od zgodnjih raziskav do dejavnosti po prihodu na trg. Podjetje ponuja rešitve, kot so decentralizirane klinične raziskave, ocenjevanje srčne varnosti, laboratorijske storitve za zgodnje klinične raziskave, medicinsko slikanje, regulatorne informacije in dokazi iz resničnega sveta. ICON plc ima tudi terapevtsko strokovno znanje na področjih, kot so bolezni srca in ožilja, onkologija, interna medicina, celične in genske terapije ter podobna biološka zdravila, pri čemer združuje analizo podatkov s pristopi, osredotočenimi na paciente, da pomaga napredovati klinične programe.
Senior Clinical Research Associate, Oncology Trials — Romania
Monitor oncology clinical trials remotely in Romania for ICON’s sponsor-dedicated research services. Oversee study sites, compliance, data quality, and trial delivery.
Opis
- Manage clinical trial activities in line with study protocols, regulations, and industry standards.
- Lead technically complex monitoring work, emphasizing quality and ongoing improvement.
- Check that trial sites follow study protocols, regulatory requirements, and Good Clinical Practice (GCP).
- Visit sites to evaluate performance, address issues, and support effective trial delivery.
- Work with cross-functional teams to ensure data is collected and reported accurately and on time.
- Train and advise site staff and fellow Clinical Research Associates.
- Build productive relationships with site teams and stakeholders to support efficient trial operations.
Zahteve
- Bachelor’s degree in a relevant science or healthcare field.
- Substantial Clinical Research Associate experience and a strong grasp of clinical trial procedures and regulatory requirements.
- Previous on-site monitoring experience with oncology trials.
- Expert knowledge of monitoring, data integrity, and site management, plus proficiency with relevant clinical trial software and tools.
- Strong communication, interpersonal, and stakeholder management abilities, including the capacity to influence and promote compliance in a complex setting.
- Available to travel as needed, approximately 60%.
- Authorized to work legally in Romania.
Ugodnosti
- Competitive base pay with performance incentives.
- Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programs and wellbeing resources.
- Structured training and career development opportunities.