CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services yra sutartinių tyrimų organizacija, aptarnaujanti biotechnologijų ir farmacijos įmones viso klinikinės plėtros proceso metu. Jos veikla apima klinikinių tyrimų vykdymą, reguliavimo strategiją, laboratorines ir bioanalitines paslaugas, realaus pasaulio įrodymus bei tyrimų centrų valdymą I–IV fazės tyrimuose. CTI turi patirties retų ligų, ląstelių ir genų terapijos, onkologijos, neurologijos bei transplantacijos srityse. Įmonė padeda kurti tyrimus, valdyti tyrimų vietas, įdarbinti pacientus, vykdyti stebėseną, užtikrinti saugumą ir farmakologinį budrumą, atlikti biometrinę analizę bei užtikrinti kokybę. Įmonė derina integruotas tyrimų paslaugas su į pacientą orientuotais tyrimais ir pasaulinėmis reguliavimo gairėmis.

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.

Aprašymas

  • 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

Reikalavimai

  • 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

Privalumai

  • 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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