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Parexel
Parexel
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Parexel este o organizație globală de cercetare clinică ce deservește companii biofarmaceutice pe parcursul dezvoltării de medicamente noi. Activitatea sa acoperă studii clinice de fază I–IV, gestionarea portofoliilor și a studiilor, strategia de reglementare, accesul la piață și planificarea ciclului de viață. Cu peste 21.000 de profesioniști, Parexel îmbină expertiza clinică, de reglementare și terapeutică cu perspectivele pacienților și designuri inovatoare ale studiilor. Compania sprijină cercetarea în domenii precum oncologia, neuroștiințele și bolile rare, punând accent pe eficientizarea dezvoltării clinice și pe orientarea acesteia către pacienți.
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Locurile de muncă ale companiei

Senior Clinical Research Associate, UK Remote

Lead oncology trial monitoring across UK investigator sites for Parexel, supporting patient safety, data quality, regulatory compliance, and inspection readiness.

GBRegatul UnitRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Maintain compliance with study protocols, ICH-GCP, regulations, and company procedures across assigned sites
  • Assess site performance, recommend targeted actions, escalate major issues, and support corrective action plans
  • Confirm that informed consent is properly obtained and documented
  • Identify protocol deviations, violations, pharmacovigilance concerns, and site risks affecting patient safety or data integrity
  • Carry out remote and on-site monitoring according to the Clinical Monitoring Plan and Study Monitoring Plan
  • Review and verify source documents to confirm clinical data is accurate, complete, and properly supported
  • Oversee protocol deviation reporting, follow-up actions, and data-query resolution
  • Check investigational product accountability, storage, security, dispensing, administration, reconciliation, and documentation
  • Record monitoring findings and study activities in reports, follow-up letters, communication logs, and other required records
  • Confirm that delegated site staff are appropriately trained for their study responsibilities
  • Track observations, action items, site status, and study progress in required systems
  • Review site records, training compliance, delegation logs, enrollment logs, accountability records, and essential documents for inspection readiness
  • Attend investigator, sponsor, monitoring, and project team meetings
  • Work with the primary Site Manager and relevant stakeholders to support study goals, deliverables, and timelines

Cerințe

  • Bachelor’s degree, Registered Nurse qualification, or an equivalent combination of education, training, and experience
  • Clinical research monitoring experience, including oncology trials and knowledge of RECIST criteria
  • Working knowledge of ICH-GCP, relevant regulations, and clinical trial processes
  • Experience performing both on-site and remote monitoring
  • Strong verbal and written communication, presentation, organizational, and interpersonal abilities
  • Ability to develop and sustain effective relationships with investigator-site staff and study stakeholders
  • Proficiency in the local language
  • Advanced or fluent English proficiency
  • Experience in clinical research and regulated work environments
  • Comfort using clinical trial systems, monitoring procedures, and evolving technologies
  • Adaptability when priorities change while maintaining study objectives and timelines

Beneficii

  • Remote or home-based working arrangement
  • Ongoing learning and professional development
  • Flexible working environment
  • Environment focused on professional growth
  • Opportunity to support innovative therapies and improve patient outcomes

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