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. Detail-oriented and organized professional to support critical clinical data management activities, handle study documentation, ensure data accuracy, and maintain regulatory compliance throughout the study lifecycle. 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
- Required: 1-2 years’ experience in a research environment or related experience.
- Preferred: BS degree in Life Science/Pharmacy or equivalent/related discipline is preferred; relevant and equivalent experience in lieu of educational requirements accepted.
- 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
- Clinical data management
- Data entry and quality checks
- Document scanning and indexing
- eTMF/TMF management
- GCP and ICH guidelines
Education
- BS degree in Life Science/Pharmacy or related discipline preferred; equivalent experience considered.
Additional Requirements
- Work environment includes laboratory/clinical settings with exposure to equipment; occasional domestic travel.
- Physical requirements include sitting/standing for long periods, repetitive hand movements, and light to moderate lifting.
- Fast-paced, process-driven environment with emphasis on adherence to study protocol and timelines.