CTI Clinical Trial and Consulting Services

Clinical Research Associate II

CTI Clinical Trial and Consulting Services

full-time

Posted on:

Location Type: Remote

Location: Czech

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Tech Stack

Google Cloud Platform

About the role

  • Serve as main CTI contact for assigned study sites
  • Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP
  • Assist with study start-up activities, including feasibility, pre-study activities and site selection
  • Collect, review and track essential/regulatory documents
  • Participate in and complete all general and study specific training as required
  • Participate in investigator, client and project team meetings
  • Create and implement subject enrollment strategies for assigned study sites
  • Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
  • Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
  • Conduct remote monitoring and complete the related activities in accordance with study specific Monitoring Plan
  • Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
  • Assist with project-specific activities as member of Project Team
  • May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)
  • May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures
  • Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available.
  • Provide regular updates to Sponsor/ Client
  • Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments
  • Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
  • Identify site issues and implement corrective actions or escalate as appropriate
  • Liaise with Clinical Data Management for data cleaning activities
  • Assist in preparing and coordinating Investigator and client meetings and attend meetings as necessary

Requirements

  • At least 2 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
  • Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources
  • Previous experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO
  • Experience in transplantation (preferably)
  • Good knowledge of the regulatory process in the country
  • Lives in or near Prague (preferably)
Benefits
  • We invest in your professional growth.
  • Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel.
  • We also encourage ongoing education to help you achieve your professional goals.
  • We support your work-life balance with hybrid work opportunities.
  • Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial monitoringsite managementregulatory document reviewsubject case report form retrievalsource document reviewinvestigational product managementdata cleaningstudy start-up activitiesfeasibility assessmentclinical research study conduct
Soft Skills
communicationorganizationalproblem-solvingteam collaborationattention to detailtime managementadaptabilityinterpersonal skillsnegotiationtraining facilitation
Certifications
Bachelor's Degree in allied healthRN with Associate's Degree3-year Nursing Diploma