CTI Clinical Trial and Consulting Services

Clinical Research Associate II – Senior Clinical Research

CTI Clinical Trial and Consulting Services

full-time

Posted on:

Location Type: Remote

Location: Germany

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Job Level

Senior

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])
  • Assist with or oversee study start-up activities
  • Collect, review and track essential/regulatory documents
  • 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 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

Requirements

  • 3 - 5 years clinical research experience as a CRA or related profession in Germany incl. independent monitoring experience in Germany
  • Life science background
  • Excellent knowledge in ICH-GCP and regulatory requirement
  • Fluent (at least Level B2) in spoken and written language German and English.
Benefits
  • Health insurance
  • Professional development opportunities
  • Hybrid work opportunities
Applicant Tracking System Keywords

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

Hard Skills & Tools
clinical researchmonitoringregulatory document reviewsubject enrollment strategiessite managementinvestigational product accountabilitycase report form retrievalsource document reviewproject-specific activities
Soft Skills
communicationteam collaborationorganizational skills
Certifications
ICH-GCP certification