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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

Site Contract Specialist – Remote in Poland

Remote, full-time role in Poland supporting confidentiality and clinical trial agreements for CTI Clinical Trial and Consulting Services. The position coordinates contract negotiations, execution, tracking, and regulatory file management.

PLPoloniaRemoteNormă întreagăJuniorNivel mediuLimbă Obligatorie: englezăGeneralSpecialist contracte

Descriere

  • Contact study sites and follow up as needed to convert confidentiality agreement (CDA) and clinical trial agreement (CTA) drafts
  • Manage contract language within approved sponsor guidelines and collaborate with legal counsel on revisions and negotiations
  • Coordinate the completion and execution of CDAs and CTAs
  • Participate in internal and external project meetings and provide updates on CDA and CTA progress
  • Maintain contract files and internal and external CDA and CTA tracking records
  • Update CTA status in the internal study start-up module for assigned studies
  • Support contract preparation, review, revision, execution, and filing
  • Inform relevant stakeholders about key terms, including expiration dates, renewal provisions, and compliance obligations
  • Support CDA preparation, review, negotiation, execution, and filing
  • Maintain CDA tracking records and archives
  • Process new consultant documentation and maintain related files

Cerințe

  • Paralegal certification or an associate degree
  • At least two years of experience in a professional administrative or business role
  • Experience with a pharmaceutical company or Clinical Research Organization (CRO) preferred
  • Basic knowledge of medical and pharmaceutical terminology preferred

Beneficii

  • Structured mentoring and leadership development courses
  • Tuition reimbursement
  • Dedicated training department
  • Comprehensive health benefits
  • Vacation packages
  • Hybrid work-from-home opportunities
  • Paid parental leave
  • CTI Cares program
  • Support for work-life balance

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