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About the Role
As the world’s largest FSP organisation, with over 90 sponsor partnerships, ICON offers stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
Responsibilities
- 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 to ensure data integrity and subject safety.
- 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 and the client's 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
- 5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits.
- At least 2 years monitoring solid tumor clinical trials.
- 1+ years early development oncology trial experience and/or Phase I or Phase III Oncology trial experience.
- Solid tumor clinical trial experience is required.
- 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.
- Experience activating sites.
- Experience training site staff.
- Experience supporting sites and/or sponsors in regulatory inspections.
- Experience working within a Functional Services (or in-house) monitoring model is preferred.
- Willing to travel up to 50%.
Skills
- Oncology monitoring techniques
- Risk-Based Monitoring
- Veeva systems
Location
- Texas
Work Type
- On-site
- Remote
- Hybrid
Experience Level
- Senior
- 5+ years monitoring clinical trials
- 2+ years monitoring solid tumor clinical trials
- 1+ years early development oncology trial experience
- 1+ years Phase I Oncology trial experience
- 1+ years Phase III Oncology trial experience
Education Level
- Bachelor’s degree (scientific field preferred)
Salary/Compensations
- Competitive base salary and performance related incentives
Benefits
- 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
About the Company
- At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
- As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
Equal Opportunity
- ICON is an equal opportunity employer.
- We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
- If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.