In-House CRA: Path to Traveling Clinical Researcher

Rho, Inc.

Poland

Remote

PLN 120,000 - 180,000

Full time

10 days ago

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Job summary

Rho, Inc. is actively hiring an In-House Clinical Research Associate to support monitoring activities, data review, and regulatory documentation within a CRO setting.

This role offers growth into traveling CRA responsibilities and close collaboration with Project Managers and Lead CRAs. You will manage CTMS data, assist with regulatory documents, and coordinate with sites to ensure compliance with ICH/GCP and study protocols.

Qualifications

  • Bachelor’s degree in life science with 1 year of CRO/pharma/biotech document management experience
  • Understanding of ICH/GCP guidelines and regulatory submissions
  • Desire to grow into traveling CRA role

Responsibilities

  • Collect, track and review investigational site records relating to subject screening and enrollment
  • Assist in the development of study plans and status reports
  • Collect, track, and review all site regulatory documents
  • Assist with development and review of Informed Consent Forms
  • Interact with sites, clients, vendors and internal study team members
  • Maintain the clinical trials management system (CTMS) and other project tracking tools
  • Track study supplies and coordinate shipments of supplies to sites as needed
  • Manage the study Trial Master File (TMF) and ensure periodic TMF audits
  • Coordinate work with CRAs monitoring on-site
  • Perform on site co-monitoring and remote monitoring activities
  • Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines

Skills

Life science background
Strong communication
English fluency
Regulatory knowledge

Education

Bachelor's degree in life sciences

Tools

CTMS experience
Regulatory databases

Job description

Rho, Inc. is actively hiring an In-House Clinical Research Associate to support monitoring activities, data review, and regulatory documentation within a CRO setting.

This role offers growth into traveling CRA responsibilities and close collaboration with Project Managers and Lead CRAs. You will manage CTMS data, assist with regulatory documents, and coordinate with sites to ensure compliance with ICH/GCP and study protocols.

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