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CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services
1.001 – 5.000 Angajați
Asistență medicalăBiotehnologieConsultanță
CTI Clinical Trial and Consulting Services este o organizație de cercetare contractuală care deservește sponsori din domeniul biotehnologiei și industriei farmaceutice pe parcursul întregului proces de dezvoltare clinică. Activitatea sa include desfășurarea studiilor clinice, strategia de reglementare, servicii de laborator și bioanalitice, dovezi din lumea reală și gestionarea centrelor de cercetare în studii de fază I–IV. CTI are experiență în domenii precum bolile rare, terapiile celulare și genice, oncologia, neurologia și transplantul, oferind sprijin pentru proiectarea studiilor, gestionarea centrelor, recrutarea pacienților, monitorizare, siguranță și farmacovigilență, biostatistică și asigurarea calității. Compania combină serviciile integrate pentru studii clinice cu cercetarea centrată pe pacient și îndrumarea globală în materie de reglementare.
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Locurile de muncă ale companiei

Senior Clinical Research Associate II – UK Remote

Senior Clinical Research Associate II overseeing UK clinical trial sites for CTI Clinical Trial and Consulting Services. The role includes site visits, remote monitoring, enrollment support, and regulatory compliance.

GBRegatul UnitRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Act as CTI’s primary contact for assigned clinical trial sites
  • Carry out pre-study, site initiation, interim monitoring, and close-out visits
  • Deliver all site visit documentation in line with the Monitoring Plan and required deadlines
  • Support or lead study start-up, feasibility, pre-study, and site selection activities
  • Gather, review, and maintain essential and regulatory documentation
  • Complete required training and attend investigator, client, and project team meetings
  • Develop and execute subject enrollment plans for assigned sites
  • Oversee the storage, dispensing, and accountability of investigational products and trial materials
  • Manage site activities and report site status to the Clinical Project Manager
  • Perform remote monitoring in accordance with the study-specific Monitoring Plan
  • Use systems and reports to monitor subject status, CRF retrieval, source document review, regulatory records, and investigational products
  • Contribute to project-specific work as a member of the Project Team

Cerințe

  • Three to five years of clinical research experience as a CRA or in a related profession
  • Background in life sciences
  • Strong knowledge of ICH-GCP and applicable regulatory requirements
  • Ability to conduct pre-study, site initiation, interim monitoring, and close-out visits
  • Ability to complete site visit deliverables within required deadlines
  • Knowledge of applicable regulations, standard operating procedures, and ICH-GCP
  • Ability to support or oversee study start-up, feasibility, pre-study, and site selection activities
  • Ability to collect, review, and track essential and regulatory documents
  • Ability to complete required general and study-specific training
  • Ability to participate in investigator, client, and project team meetings, including presentations
  • Ability to develop and implement subject enrollment strategies
  • Ability to manage investigational products and trial-related materials
  • Ability to conduct site management and remote monitoring activities
  • Ability to use systems and reports to track subject status, CRF retrieval, source document review, regulatory documents, and investigational products

Beneficii

  • Structured mentoring program
  • Leadership development courses
  • Dedicated training department
  • Support for continuing education
  • Hybrid work opportunities
  • CTI Cares community and global giving opportunities
  • Work contributing to the development of life-changing treatments

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