CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services ir līgumisko pētījumu organizācija, kas apkalpo biotehnoloģiju un farmācijas uzņēmumus visā klīniskās izstrādes procesā. Tās darbība ietver klīnisko pētījumu īstenošanu, regulatīvo stratēģiju, laboratorijas un bioanalītiskos pakalpojumus, reālās pasaules pierādījumus, kā arī pētniecības centru pārvaldību I–IV fāzes pētījumos. CTI ir pieredze tādās jomās kā retās slimības, šūnu un gēnu terapija, onkoloģija, neiroloģija un transplantācija. Uzņēmums atbalsta pētījumu izstrādi, pētījumu vietu pārvaldību, pacientu piesaisti, monitoringu, drošumu un farmakovigilanci, biometriju un kvalitātes nodrošināšanu. Uzņēmums apvieno integrētus pētījumu pakalpojumus ar uz pacientu vērstu pētniecību un globālām regulatīvajām vadlīnijām.

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.

Apraksts

  • 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

Prasības

  • 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

Priekšrocības

  • 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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