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Clinical Data Monitor, Phase I - Dallas, TX

Fortrea
Full-time
On-site
Dallas, TX
Clinical Research and Development

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Role Summary

Clinical Data Monitor, Phase I – Dallas, TX. Support critical clinical data management activities, manage study documentation, ensure data accuracy, and maintain regulatory compliance. Manage project files, perform data entry, and support operational tasks throughout the study lifecycle. This is a full-time, office-based position in Dallas, TX.

Responsibilities

  • Understanding and following project-specific guidelines for scanning, indexing, data entry, tracking, and administrative tasks.
  • Scanning and indexing study-related documents such as CRFs and other essential records.
  • Entering clinical data into databases accurately using source documents and performing quality checks.
  • Assisting with EDC user account activations, deactivations, and modifications under supervision.
  • Supporting decommissioning activities, including QC of PDFs/media, preparing shipment packages, and tracking acknowledgments.
  • Maintaining project files in eTMF/TMF and ensuring compliance with SOPs, GCP, and ICH guidelines.
  • Performing archiving duties for both paper and electronic media and keeping accurate records of all tasks.
  • All other duties as needed or assigned.

Qualifications

  • BS degree in Life Science/Pharmacy or equivalent/related discipline is preferred.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • 1-2 years’ experience in a research environment or related experience.
  • Strong attention to detail and accuracy.
  • Excellent communication and organizational skills.
  • Ability to work collaboratively with a team.
  • Experience in clinical research or related field is a plus.

Skills

  • Data entry and data management
  • Attention to detail and accuracy
  • Communication and teamwork
  • Regulatory compliance knowledge (GCP, ICH)
  • Electronic data capture (EDC) system familiarity

Education

  • BS degree in Life Science/Pharmacy or equivalent preferred

Additional Requirements

  • Work environment includes laboratory/clinical setting with exposure to electrical equipment; occasional domestic travel.
  • Physical requirements include ability to sit/stand for extended periods and light lifting up to 15–20 lbs.
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