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
- Plan and conduct bi-weekly site-management calls to facilitate clear actions and establish timelines. After each call, send summary emails and update the Veeva CTMS system accordingly.
- 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 internal compliance standards.
Required Skills for SMa CRA
- Strong ability to engage remotely with sites and stakeholders.
- Proficiency in using Veeva CTMS and maintaining thorough, accurate documentation.
- Analytical skills and the capability to prioritize based on risk.
- Excellent collaboration and communication abilities.
- Comprehensive knowledge of ICH-GCP guidelines and Standard Operating Procedures (SOPs).
SMa Model Expectations
- This is primarily a non-traveling role, with the SMa CRA readily available to support sites remotely.
- Typical allocation is approximately 1.0 Full-Time Equivalent (FTE) across 1 - 2 protocols.
- The standard cadence for site contact is bi-weekly, though this may be adjusted depending on study and site performance.
- Conduct on-site monitoring or co-monitoring when required
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.