Lead Clinical Research Associate
Core
Lead Clinical Research Associate providing leadership, oversight, and mentorship for regional clinical trials with minimal site assignments and a low-travel model.
Role type
Senior Lead Clinical Research Associate (Regional Oversight)
Builds
Clinical study execution and data integrity for global clinical projects
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Clinical trial monitoring, project timeline management, data cleaning, compliance oversight, CAPA development, site audit coordination, safety information flow, clinical supplies management, team mentorship, regulatory submission support
Preferred skills
Oncology, Radiation Therapy, Radiopharmaceuticals, CAR-T Therapy, Cell Therapy, Gene Therapy, Nuclear Medicine, GI disorders (Chron's, Ulcerative Colitis, IBS)
Technologies
MS Office
Responsibilities
Monitor project timelines, patient enrollment, and data cleaning; review monitoring visit reports; act as communication line between monitors and project management; lead project team calls; provide training and prepare materials; supervise source data verification and data queries; manage Investigational Product and study supplies; review essential study documents and ISF/TMF; ensure data integrity and compliance; coordinate safety reporting and protocol deviations; manage site contracting and payments; conduct supervised monitoring visits; prepare for and coordinate site audits; mentor newly promoted Lead CRAs; deliver presentations at Investigator Meetings.
Seniority
Senior, hands-on IC with leadership focus