# Senior Clinical Research Associate - Oncology - Texas

**Company**: ICON Strategic Solutions
**Location**: Texas
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/US-Houston-TX/Senior-Clinical-Research-Associate_JR160990?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

As a Senior Clinical Research Associate - Oncology - Texas at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

In this role, you will be responsible for performing site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness.

Key responsibilities include:

- Performing remote and on-site monitoring/co-monitoring visits to ensure data integrity and subject safety in the client's trials

- Acting as the primary contact and facilitating efficient communications between the client's clinical trial team and the sites

- Managing site essential document collection and TMF reconciliation with site files

- Supporting sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirming approvals

- Regularly reviewing site Key Risk Indicator (KRI) metrics, issues, and action items to detect trends and ensure prompt resolution

- Independently determining root causes and developing/implementing site Corrective Action and Preventive Action (CAPA) plans

- Delivering training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and regulations

- Supporting sites and the client's regulatory inspections

- Contributing to site identification, driving site feasibility and qualification progress, and supporting site activation activities

- Leading site engagement initiatives and fostering relationships with key Oncology sites and networks

To qualify for this role, you will need:

- A Bachelor's degree in a scientific field

- 5+ years of experience monitoring clinical trials independently, conducting on-site and remote monitoring visits, with at least 2 years of experience monitoring solid tumor clinical trials

- 1+ year of experience in early development oncology trials and/or Phase III Oncology trials

- Solid tumor clinical trial experience

- Experience utilizing Veeva systems is highly preferred

- 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, activating sites, training site staff, and supporting sites and/or sponsors in regulatory inspections

- Willingness to travel up to 50%

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development, which may include:

- Competitive base salary and performance-related incentives

- Health and wellbeing programmes, including medical, dental, and vision coverage where applicable

- Retirement and pension plans

- Life assurance and disability coverage

- Employee assistance programmes and wellbeing resources

- Learning and development opportunities through structured training and career pathways

## Skills

### Required
- GxPs
- Oncology monitoring techniques
- Risk-Based Monitoring
- Veeva systems
- Clinical trials monitoring

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