Clinical Research Associate - Oncology

Overview

Clinical Research Associate – ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Role: Clinical Research Associate (CRO and/or Pharma monitoring and Oncology experience required)

Location: Must be based in the UK, nationwide travel

Engagement: Fully sponsor dedicated

• Allocates, initiates and conducts trials; conducts site selection for potential sites, evaluates capabilities, and recommends sites to participate in the clinical trial. Acts as the frontline liaison between ICON and sites to ensure successful collaboration and delivery of milestones.
• Manages assigned study sites and networks (where applicable), conducting phase I–IV protocols according to the monitoring plan and client procedures. Performs Site Initiation Visits and ensures site personnel are trained on all trial-related aspects. Provides continuous training for amendments and new site personnel as required.
• Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure protocol, GCP, and regulatory compliance, data integrity and patient safety. Keeps electronic systems up to date with job-relevant information.
• Ensures study milestones for responsible sites are met (e.g., study startup, recruitment, database analyses, closeout). Performs Site Closeout activities per SOPs and regulations to ensure follow-up and archiving requirements are understood. Participates in onboarding, disease indication and project-specific training as required.
• Documents monitoring activities according to ICON standards. Collaborates with CRA Group Head/CSM on recruitment plans and contingency actions. Participates in audit readiness and inspection activities and implements corrective actions within timelines.
• Performs additional tasks as assigned. Delivers quality data and maintains compliance with quality standards.
• Monitors studies per current legislation, ICH/GCP and client standards. Ensures timely delivery of high-quality, robust data to support Trial Monitoring goals. Identifies and resolves issues at sites and escalates as appropriate.
• Collaborates with internal stakeholders and site personnel to manage data query resolution, ensures the Investigator Folder is up to date, and maintains current sTMFs. Supports implementation of innovative processes and technologies related to data management and site oversight.
• Negotiates investigator remuneration and prepares financial contracts between ICON and investigative sites. Ensures that payments are triggered appropriately.

• Right to work in the UK
• Up to 2 years pharmaceutical/CRO industry experience
• Good knowledge of the drug development process, specifically clinical trials/research
• Knowledge of international standards (GCP/ICH, FDA, EMEA)
• 12+ months' monitoring experience required

• Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings
• A minimum of 50% overnight travel may be required

Our success depends on the quality of our people. We’re committed to building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme (Life Works), offering 24-hour access to a global network of professionals who support your and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit ICON’s careers site for more information about benefits and accommodations.

ICON is committed to equal opportunity and providing an inclusive and accessible environment for all candidates. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you require a reasonable accommodation during the application process or to perform essential functions, please inform us.