CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services ir līgumisko pētījumu organizācija, kas apkalpo biotehnoloģiju un farmācijas uzņēmumus visā klīniskās izstrādes procesā. Tās darbība ietver klīnisko pētījumu īstenošanu, regulatīvo stratēģiju, laboratorijas un bioanalītiskos pakalpojumus, reālās pasaules pierādījumus, kā arī pētniecības centru pārvaldību I–IV fāzes pētījumos. CTI ir pieredze tādās jomās kā retās slimības, šūnu un gēnu terapija, onkoloģija, neiroloģija un transplantācija. Uzņēmums atbalsta pētījumu izstrādi, pētījumu vietu pārvaldību, pacientu piesaisti, monitoringu, drošumu un farmakovigilanci, biometriju un kvalitātes nodrošināšanu. Uzņēmums apvieno integrētus pētījumu pakalpojumus ar uz pacientu vērstu pētniecību un globālām regulatīvajām vadlīnijām.

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.

Apraksts

  • 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.

Prasības

  • 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.

Priekšrocības

  • 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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