Clinical Research Associate / Senior CRA
Core
Conducting monitoring visits for clinical studies in Oncology, Ulcerative Colitis, and Antibiotics therapeutic areas to ensure protocol compliance and data integrity.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data and regulatory submissions
Domain
Clinical Research / Life Sciences
Required skills
Site selection and initiation, Routine monitoring, Close-out visits, Source data verification, Investigational product accountability, TMF reconciliation, Regulatory submission support, Study-specific training
Preferred skills
Oncology, Ulcerative Colitis, or Antibiotics trial experience
Technologies
MS Office
Responsibilities
Prepare, conduct, and report on monitoring visits (site selection, initiation, routine, close-out); Ensure compliance with study protocols, ICH-GCP, and regulatory requirements; Monitor patient recruitment, timelines, and site performance; Perform source data verification and manage data queries; Oversee investigational product accountability and documentation; Maintain Investigator Site Files (ISF) and support TMF reconciliation; Deliver study-specific training to investigators and site staff; Support regulatory submissions and audit preparation.
Seniority
Senior, hands-on IC