Clinical Research Associate, Cell Therapy - Mid Atlantic
Core
Field-based Clinical Research Associate responsible for monitoring study conduct, site initiation, and closure for clinical trials in the Mid-Atlantic region.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial studies for AstraZeneca
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
Site monitoring, Source Data Verification (SDV), Regulatory document management, Investigator training, Data query resolution, Serious Adverse Event (SAE) reporting, Site quality risk assessment, eTMF management, Investigational product accountability
Preferred skills
Experience with Cell Therapy studies, Local Study Associate Director (LSAD) responsibilities
Technologies
CTMS, eTMF
Responsibilities
Prepare, initiate, monitor, and close assigned sites; Train investigators on ICH-GCP and Risk Based Quality Management (RbQM); Perform onsite and remote monitoring visits; Conduct Source Data Review (SDR) and CRF review; Manage study supplies and investigational product accountability; Ensure timely reporting of Serious Adverse Events (SAEs); Support audit and regulatory inspection readiness.
Seniority
Mid-level IC