Fortrea seeks a BDC Study Designer to configure electronic data capture systems for Phase I clinical trials. The role involves translating study protocols into practical data collection solutions, maintaining compliance with regulatory standards, and collaborating across clinical research teams.
Responsibilities
- Configure studies within BDC system, including recruitment, screening, and on-study components aligned with protocols
- Translate clinical study protocols into electronic data collection forms and CRF fields
- Perform post go-live updates and system maintenance to support ongoing study requirements
- Collaborate with Clinical Operations, Biometrics, Project Managers, and IT teams on study delivery
- Ensure compliance with regulatory requirements, GCP, ICH guidelines, and Good Documentation Practices
Requirements
- Bachelor's degree in Life Sciences, Clinical Research, IT, or related scientific/technical discipline
- Minimum 3–4 years clinical research experience, preferably Phase I studies
- Understanding of Electronic Data Capture systems and clinical trial processes
- Working knowledge of GCP, ICH Guidelines, and 21 CFR Part 11 requirements
- Experience with clinical source documentation and data collection workflows
- Strong organizational and cross-functional collaboration skills
- Medical terminology knowledge and regulated environment experience preferred
Vacancy posted a month ago
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