Lead CRA
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
- 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.
- Develop and maintain strong, collaborative relationships with investigators, site staff, and key stakeholders to promote efficient and compliant trial execution.
Required Qualifications
- 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