Senior Clinical Research Associate
ICON plc
Summary
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.
Job description
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 (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
- 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
Qualifications
- Bachelor's degree (scientific field preferred)
- 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 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%
Requirements
- Bachelor's degree (scientific field preferred)
- 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 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%
Benefits
- Competitive base salary
- Performance incentives
- Medical, Dental & Vision
- Retirement plans
- Pension plans
- Life assurance
- Disability coverage
- Employee assistance programs
- Wellbeing resources
- Learning and development
Company overview
ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.