PRAHS

Clinical Research Associate (I,II and Senior)

Posting Locations PL
Posted Date 19 hours ago(6/13/2025 8:24 AM)
ID
2025-120122

Overview

As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

  • Be the go-to expert and main contact for clinical trial sites from start to finish.
  • Build strong, lasting relationships with site staff to ensure smooth trial execution.
  • Monitor clinical sites to ensure data quality and patient safety in line with GCP and study protocols.
  • Master the study protocol and procedures to support site success.
  • Drive site readiness by collaborating with cross-functional teams.
  • Help identify and validate new study sites.
  • Ensure all regulatory and trial documentation is up-to-date and accurate.
  • Lead and document site visits (initiation, monitoring, close-out, etc.) with clarity and precision.
  • Communicate proactively with investigators about protocol, recruitment, compliance, and performance.
  • Coordinate with internal teams and external partners (vendors, IRBs, regulators) to support study milestones.
  • Keep systems like CTMS and eTMF accurate and current.
  • Support inspections and audits—and even lead them when needed.
  • Mentor and co-monitor with peers to share best practices.

Qualifications

  • B.A./B.S. preferred with strong emphasis in science and/or biology
  • Min. 1 year of direct monitoring experience

  • Previous experience in oncology trials or ready to monitor oncology trials will be an asset 

  • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
  • Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
  • Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Demonstrated ability to mentor/lead
  • Hands on knowledge of Good Documentation Practices
  • Proven Skills in Site Management including independent management of site performance and patient recruitment
  • Demonstrated high level of monitoring skill with independent professional judgment
  • Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
  • Ability to understand and analyze data/metrics and act appropriately
  • Experience with conducting site motivational visit designed to boost site enrollment
  • Capable of managing complex issues, working solution-oriented
  • Performs root cause analysis and implements preventative and corrective action

 

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