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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

Monitor clinical trial sites for CTI, a global clinical research CRO, and oversee site visits, regulatory records, investigational products, and study deliverables. Coordinate site management and study activities with investigators, sponsors, clients, and internal teams.

USStatele Unite ale AmericiiKYKentuckyRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Act as CTI’s primary contact for assigned clinical trial sites.
  • Conduct pre-study, initiation, interim monitoring, and close-out visits.
  • Deliver accurate site visit reports and other outputs on the Monitoring Plan schedule.
  • Support study start-up, feasibility reviews, pre-study work, and site selection.
  • Gather, review, and track essential and regulatory documentation.
  • Take part in investigator, client, and project team meetings.
  • Develop and carry out strategies to support subject enrollment.
  • 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 line with study-specific Monitoring Plans.
  • Use study systems and reports to track subject status, CRF collection, source document verification, regulatory records, and investigational products.
  • Contribute to project tasks and the preparation of CRFs and study documents.
  • Help translate, adapt, and review patient information, informed consent forms, protocol summaries, and other study materials.
  • Prepare regulatory submission documents and follow submissions through approval when applicable.
  • Keep the Sponsor or Client informed with regular updates.
  • Support and attend investigator and client meetings.
  • Coordinate with Clinical Data Management on data cleaning.
  • Spot site issues, take corrective action, or escalate them as needed.
  • Maintain the Investigator Site File and Trial Master File for assigned sites.
  • Assist with contract negotiations, investigator payments, and site payment tracking when applicable.

Cerințe

  • Have at least one year of clinical trial monitoring experience, or equivalent experience as determined by CTI Management and Human Resources.
  • Hold a bachelor’s degree or higher in an allied health field such as nursing, pharmacy, or health or natural science; alternatively, be an RN with an associate degree, hold a three-year nursing diploma with at least two years of clinical nursing experience, or have equivalent experience as determined by CTI Management and Human Resources.
  • Have prior experience conducting clinical research in a hospital, pharmaceutical company, or CRO.
  • Show a record of successful performance in a CRA role.
  • On-site monitoring experience of at least one year is preferred.
  • Follow applicable regulations, SOPs, and ICH GCP.
  • Be able to complete general and study-specific training.
  • Have experience with clinical trial systems and reports, CRFs, source data verification, regulatory documentation, investigational products, ISFs, and TMFs.
  • Be able to support regulatory submissions and contract negotiations when applicable.

Beneficii

  • Structured mentoring program.
  • Leadership courses.
  • Tuition reimbursement.
  • Dedicated training department.
  • Generous health benefits.
  • Vacation packages.
  • Hybrid work-from-home opportunities.
  • Paid parental leave.
  • CTI Cares program.
  • Work-life balance support.

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