Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team.
The freelance CRA will ensure effective, risk-proportionate monitoring of Lindus Health's global portfolio of clinical trials and will focus on supporting a major trial across 15+ US sites involving over 7,000 patients. The role involves preparation, conduct, and reporting for all types of monitoring visits, as well as central monitoring through our Citrus platform.
As a Medical/Clinical Data Reviewer you will be joining the world’s largest & most comprehensive clinical research organisation. You will serve as a Clinical Data Reviewer and identify any errors in data by performing data review that require further clarification with the study sites. You will also perform ongoing review of clinical/medical aspects of assigned patient data and documents.
The Lead Site/Study Coordinator supports medical institutions for clinical trial activities. They supervise site staff, assist with study logistics, data entry, and monitor visits. They act as a communication line between the Milestone One Manager, medical institution staff, and the Sponsor or CRO. They also facilitate study evaluations, identify new projects, and participate in patient recruitment. They ensure compliance with protocols and enhance recruitment strategies.
Performs and coordinates all aspects of the clinical site monitoring services, assessing for protocol and regulatory compliance. Responsibilities include driving investigative site and patient recruitment, conducting source data verification, assessing drug accountability, data collection, (regulatory) document collection, performing qualification, initiation, monitoring and close out visits at investigational sites.