Parexel — жаңа дәрі-дәрмектерді әзірлеудің барлық кезеңдерінде биофармацевтикалық компанияларға қызмет көрсететін жаһандық клиникалық зерттеу ұйымы. Оның қызметі I–IV фазалардағы клиникалық зерттеулерді, портфель мен зерттеулерді басқаруды, реттеуші стратегияны, нарыққа қолжетімділікті және дәрі-дәрмектің өмірлік циклін жоспарлауды қамтиды. 21 000-нан астам маманы бар Parexel клиникалық, реттеуші және терапиялық сараптаманы пациенттер туралы түсініктермен және инновациялық зерттеу үлгілерімен ұштастырады. Компания онкология, нейроғылым және сирек кездесетін ауруларды қоса алғанда, әртүрлі бағыттардағы зерттеулерге қолдау көрсетіп, клиникалық әзірлеу үдерісін тиімдірек әрі пациентке бағдарланған етуге назар аударады.
Senior Clinical Research Associate – FSP | Parexel, Turkey Remote
Lead clinical trial monitoring and investigator-site delivery across Turkey as a Senior Clinical Research Associate supporting Parexel’s global life sciences programs.
Сипаттама
- Ensure clinical trials follow the Study Monitoring Plan, applicable regulations, GCP, and client requirements.
- Manage trial operations at assigned investigator sites from activation through database lock.
- Act as the primary contact for assigned investigator sites.
- Partner with or escalate to the SCP to maintain high-quality site delivery.
- Attend investigator meetings virtually or in person when required.
- Support enrollment and resolve site activation and recruitment challenges.
- Coordinate site-level recruitment initiatives with the SCP and study team.
- Perform onsite and remote monitoring for site initiation, routine visits, and site close-out.
- Track site-level adverse and serious adverse events in collaboration with the Drug Safety Unit.
- Submit required reports, records, updates, and tracking on schedule, including TMF records, site reports, follow-up letters, protocol deviations, recruitment data, clinical supply updates, study progress, and metrics.
- Identify and resolve site issues while developing corrective and preventive actions.
- Resolve data queries and plan and conduct investigator-site close-out activities.
Талаптар
- Extensive knowledge of clinical trial methods, ICH/GCP, FDA requirements, and local regulations.
- At least 3 years of relevant clinical research site-monitoring experience.
- Preferably 2 years of oncology experience.
- Therapeutic experience in oncology, vaccines, internal medicine, or infectious diseases is preferred.
- Experience supporting global clinical trials.
- Fluency in English is required.
- Ability to travel extensively throughout Turkey.
- Valid driver’s license and passport required.
- Working knowledge of clinical research and development processes.
- Knowledge of global and local regulatory requirements.
- Understanding of clinical research operations, including monitoring, data collection and cleaning, and reporting.
- Knowledge of disease areas and technical topics relevant to clinical studies.
- Ability to support sponsor regulatory interactions and inspections.
- Knowledge of protocol design and feasibility assessment.
- Understanding of regional and national culture, medical practice, and their impact on trial delivery.
- Ability to assess, interpret, and present complex issues and data for risk management and mitigation.
- Bachelor’s degree in life sciences or an equivalent professional life sciences qualification, such as nursing, pharmacy, or medicine.