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.
This contract position ensures data collected for clinical studies is accurate and traceable, assists in site management, and develops clinical study materials. You will support site identification, conduct monitoring visits, perform source data verification, and track regulatory document submissions.
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.
Provides overall support to study sites and clinical project teams engaged in clinical research studies, adhering to applicable protocols, SOPs, and regulatory requirements. Acts as point of contact for study sites and expected to work independently in providing support to CRA and sites. Can have increased focus on training and development of junior staff members and can act as Lead In-house CRA.