Clinical Research Associate, Unblinded – Oncology
ICON plc
Clinical Research Associate, Unblinded, Oncology
ICON plc
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
About the role
- Perform site management activities to support Oncology site success and maintain a continuous state of inspection readiness
- Act as the primary contact and facilitate efficient communications between the clinical trial team and the sites
- Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in trials
- May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
- Promptly document monitoring activities and submit/approve visit reports
- Manage site essential document collection and TMF reconciliation with site files
- Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals
- Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution
- Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans
- Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
- Support sites during regulatory inspections
- Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities
- Lead site engagement initiatives and foster relationships with key Oncology sites and networks
Requirements
- Bachelor’s degree (scientific field preferred)
- 2+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits
- At least 2 years of monitoring IP experience
- Experience monitoring at USO IPC
- Willing to perform PSSVs and SIVs as needed
- Veeva RTSM (IRT) experience would be extremely helpful and highly preferred
- Demonstrated experience developing/maintaining site relationships and securing compliance
- Expertise in GCPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology
- Experience collaborating with sites from initial engagement through close-out phases
- Experience activating sites
- Experience training site staff
- Experience supporting sites and/or sponsors in regulatory inspections
- Experience working within an FSP (or in-house) monitoring model is preferred
- Willing to travel up to 50% domestically (USO IPC in Dallas and other US depots)
- Reside in Dallas, Texas or major hub in Texas.
