ICON plc ir globāla līgumizpētes organizācija, kas apkalpo veselības aprūpes un farmācijas nozares. Tās darbība ietver klīniskos, konsultāciju un komerciālos pakalpojumus, kas atbalsta zāļu izstrādi no agrīnas izpētes līdz darbībām pēc zāļu nonākšanas tirgū. Uzņēmums piedāvā decentralizētus klīniskos pētījumus, sirds drošuma novērtēšanu, agrīnās klīniskās laboratorijas pakalpojumus, medicīnisko attēlveidošanu, regulatīvo informāciju un reālās pasaules pierādījumu risinājumus. ICON plc ir arī terapeitiskā kompetence tādās jomās kā sirds un asinsvadu slimības, onkoloģija, iekšķīgās slimības, šūnu un gēnu terapijas, kā arī bioloģiski līdzīgas zāles. Apvienojot datu analīzi ar uz pacientu vērstām pieejām, uzņēmums palīdz attīstīt klīniskās programmas.
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.
Apraksts
- 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.
Prasības
- 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.
Priekšrocības
- 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.