Clinical Research Associate / Senior CRA
Core
Conducting clinical study monitoring visits to ensure compliance with protocols and regulations across various therapeutic areas.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance
Domain
Clinical Research / Life Sciences
Deliverable
physical/clinical work
Required skills
Source data verification, Investigational product accountability, TMF reconciliation, Site selection, Protocol compliance, Patient recruitment monitoring, Regulatory submission support, Training delivery, Risk management
Preferred skills
Oncology trial experience, Ulcerative Colitis trial experience, Antibiotics trial experience
Technologies
MS Office
Responsibilities
Conducting site initiation, routine, and close-out monitoring visits; Performing source data verification and managing data queries; Overseeing investigational product accountability; Maintaining Investigator Site Files and supporting TMF reconciliation; Delivering study-specific training to site staff; Supporting regulatory submissions and audit preparations.