- Oversee clinical trial site activities to ensure strict adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
- Conduct routine and ad hoc site visits to evaluate performance, identify risks, resolve operational challenges, and support successful study delivery.
- Partner closely with cross-functional teams to ensure accurate, timely data capture and reporting throughout the study lifecycle.
- Provide training, mentorship, and ongoing guidance to site personnel and fellow CRAs to uphold high standards of trial conduct and compliance. xohynlm
- Develop and maintain strong, collaborative relationships with investigators, site staff, and key stakeholders to promote efficient and compliant trial execution.
- 6–10+ years of CRA experience with at least 2+ years operating at a senior or Lead CRA level
- Demonstrated experience in liver disease, MASH/NASH, obesity, diabetes, or cardiometabolic clinical trials
- Experience managing complex endpoints such as liver biopsy coordination, imaging (MRI-PDFF, FibroScan), and metabolic biomarkers
- Strong knowledge of ICH-GCP and regulatory requirements
- Experience working in high-enrolling academic and community sites
- Willingness to travel as required
Contract Lead CRA - Fufín - LumaBio Partners
Descripción
Lead CRA
Todos los posibles candidatos deben leer con atención los siguientes detalles de este trabajo antes de presentar una candidatura.We are seeking an experienced Lead CRA to support Phase 2–3 clinical trials across liver and cardiometabolic indications, including MASH/NASH, obesity, and related metabolic disorders.
This role will play a critical part in ensuring high-quality site execution, regulatory compliance, and data integrity across complex, multi-center studies. The ideal candidate will bring strong therapeutic expertise alongside leadership capability within a dynamic clinical environment.
Key Responsibilities
Required Qualifications