Senior Clinical Research Associate

Senior Clinical Research Associate - Oncology Phase I - Miami, FL

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

The Sr. Clinical Research Associate (Sr. CRA) will be responsible for performing investigative site management and monitoring activities throughout the clinical trial lifecycle.

This Sr. CRA role will support the client's Oncology clinical trials to ensure data integrity, subject safety, and inspection readiness at the clinical investigative sites.

- Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness

- Act as the primary contact and facilitate efficient communications between the client's 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 the client's 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

- 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

- 5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials.

- Demonstrated experience developing/maintaining site relationships and securing compliance

- Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology

- Experience collaborating with sites from initial engagement through close-out phases

- Experience supporting sites and/or sponsors in regulatory inspections

- Experience working within a Functional Services (or in-house) monitoring model is preferred