Thane, India | Full time | Field-based | R1555979

SMa is a CRA role. Minimum 3 years of Monitoring experience is mandatory.

Role Overview

Site Management CRA (SMa) are responsible for leading structured, remote site-management activities between monitoring events to ensure that site performance remains aligned with trial metrics. SMa role involves the preparation, execution, and documentation of regular site-management contacts. Each interaction must be thoroughly captured in the Veeva CTMS (Site Communication Log), following trial guidance and the Study Monitoring Plan.

SMa CRAs are assigned to sites around the completion of site initiation monitoring (SIM) and begin providing SMa support following Enrollment Readiness (ER). The key responsibilities of the SMa CRA include conducting regular follow-ups focusing on:
Support sites with study protocol & operational process queries
Patient retention & adjudication if applicable
Informed Consent process
Support data entry & query resolution within the Electronic Data Capture (EDC) system or Case Report Form (CRF)




Patient safety review
Investigational Medicinal Product (IMP) shipments and inventory
Support sites with Labs/Vendor/electronic Clinical Outcomes Assessment (eCOA) metrics, queries and supply inventory
Support sites for Monitoring Follow Up and User Action Items to ensure timely resolution
Review Protocol Deviations (PD)
Site training (as needed)
Escalate issues to the Clinical Research Lead (CRL) when required

Key Responsibilities
Experts in both the study Protocol and Operational processes
Prepare for each site contact by thoroughly reviewing site-level metrics and identifying and prioritizing potential risks.
Maintain trackers and dashboards to provide ongoing status updates and promptly escalate any major performance challenges as they arise.
Collaborate closely with the Onsite CRA
Consistently document all site interactions and management activities in Veeva CTMS to meet

📌 Site Management Cra Thane
🏢 Iqvia
📍 Thane