Lead Clinical Research Associate
Core
Lead a clinical research team to oversee trial activities, ensure compliance, and drive timely delivery at a country or regional level.
Role type
Senior Lead Clinical Research Associate (Oversight & Mentorship)
Builds
Clinical trials (Phase II/III) across various therapeutic areas
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Clinical trial monitoring, data integrity management, regulatory compliance, team leadership, risk management, supply chain management, audit coordination, training delivery
Preferred skills
Oncology, Cell Therapy (CAR-T, Gene Therapy), Nuclear Medicine, GI disorders (Crohn's, IBS)
Technologies
MS Office, Clinical tracking systems
Responsibilities
Monitor project timelines, patient enrollment, and data cleaning; review monitoring visit reports; act as communication hub between monitors, sites, and project leads; provide training and mentorship to monitors and new Lead CRAs; manage clinical supplies and Investigational Products; coordinate site audits and CAPA implementation; manage site contracting and payments; ensure data integrity and compliance at site and regional levels.
Seniority
Senior, hands-on IC with leadership responsibilities (via careerplan.io/jobs/744000130793592-lead-clinical-research-associate-at-psi-cro)