CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services — клиникалық әзірлеу үдерісінің барлық кезеңінде биотехнологиялық және фармацевтикалық демеушілерге қызмет көрсететін келісімшарттық зерттеу ұйымы. Компанияның қызметі I–IV фазалардағы зерттеулер аясында клиникалық сынақтарды жүргізуді, реттеуші стратегияны, зертханалық және биоаналитикалық қызметтерді, нақты өмір деректерін және зерттеу орталықтарын басқаруды қамтиды. CTI сирек кездесетін аурулар, жасушалық және гендік терапия, онкология, неврология және трансплантация сияқты бағыттарда тәжірибеге ие. Компания зерттеу дизайнын, зерттеу орталықтарын басқаруды, пациенттерді тартуды, мониторингті, қауіпсіздік пен фармакологиялық қадағалауды, биометрияны және сапаны қамтамасыз етуді қолдайды. CTI біріктірілген зерттеу қызметтерін пациентке бағытталған зерттеулермен және жаһандық реттеуші кеңеспен ұштастырады.

Clinical Research Associate – France Remote

Monitor clinical trial sites in Germany for CTI, serving as their primary contact and supporting study visits, documentation, investigational products, and remote monitoring.

Сипаттама

  • Act as CTI’s primary contact for assigned clinical study sites.
  • Conduct pre-study, site initiation, interim monitoring, and close-out visits.
  • Deliver site visit documentation to quality standards and within Monitoring Plan timelines.
  • Support or oversee study start-up, feasibility reviews, pre-study activities, and site selection.
  • Gather, review, and track essential and regulatory documentation.
  • Complete required general and study-specific training.
  • Attend investigator, client, and project team meetings, and present when required.
  • Develop and carry out strategies to support subject enrollment.
  • Oversee appropriate storage, dispensing, and accountability of investigational products and trial materials.
  • Keep the Clinical Project Manager informed of site status.
  • Perform remote monitoring according to each study’s Monitoring Plan.
  • Use systems and reports to track subject status, CRF retrieval, source document review, regulatory records, and investigational products.
  • Contribute to project-specific work as part of the Project Team.

Талаптар

  • 3–5 years of clinical research experience as a CRA or in a related role.
  • Independent clinical trial monitoring experience in Germany.
  • Background in life sciences.
  • Strong knowledge of ICH-GCP and applicable regulatory requirements.
  • Fluent spoken and written English, at least B2 level.
  • Ability to conduct pre-study, site initiation, interim monitoring, and close-out visits.
  • Ability to manage sites and perform remote monitoring.
  • Ability to manage investigational products and trial-related materials.
  • Ability to collect, review, and track essential and regulatory documentation.

Артықшылықтар

  • Structured mentoring program.
  • Leadership development courses.
  • Dedicated training department.
  • Continued education support.
  • Hybrid work opportunities.
  • Opportunities to participate in CTI Cares community and charitable activities.
  • Work that contributes to treatments for patients with chronic and critical illnesses.

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