Senior Clinical Research Associate - nationwide travel

Title: Senior Clinical Research Associate

Location: United Kingdom, nationwide travel required

Sponsor dedicated

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to 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.

Responsibilities:

• Assess qualifications of potential clinical study sites.
• Implement clinical studies at participating sites.
• Manage the conduct of clinical studies at sites.
• Ensure the quality of site performance and close clinical studies.
• Document all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines.
• Train site personnel on the protocol/protocol amendments and operational aspects of the trial.
• Serve as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members.
• Develop patient recruitment strategies in conjunction with the clinical site to meet enrolment timelines.
• Ensure subjects’ rights, safety and well-being are protected.
• Ensure compliance with procedures in the event of adverse events and serious adverse events.
• Evaluate the quality and integrity of reported data.
• Assist and support data validation and data cleaning procedures.
• Identify, assess and resolve site performance, quality or compliance problems.
• Communicate with Investigators, site staff, and Sponsor Study Team Members on issues related to protocol conduct.
• Maintain audit-ready clinical trial documentation.
• Verify receipt, handling, accounting, storage conditions and availability of study medications.
• Ensure availability of non-clinical materials for sites.
• Develop strong site relationships through all phases of the trial.
• Gain an in-depth understanding of study protocols and related procedures.

Minimum Requirements:

• BA/BS, preferably in the Life Sciences, or RN.
• Minimum of 2+ years of experience in the pharmaceutical/biotechnology industry monitoring as a Clinical Research Associate.
• Strong Oncology monitoring experience in phase 1-3 clinical trials.
• Good understanding of ICH guidelines, Good Clinical Practices (GCP), and other relevant regulatory requirements.
• Strong working knowledge of EDC, IVRS, and CTMS systems.
• Proficiency in Microsoft Office.
• Ability to handle and prioritize multiple studies and projects.
• Ability to work effectively in a team/matrix environment.
• Demonstrated strengths in planning, organizational, project management, and communication skills.
• Possess a valid UK driver’s license.
• Must be willing to travel and spend 6-8 days/month on site.
• Proficient in speaking and writing English.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits designed to support your well-being and work-life balance.

• Various annual leave entitlements.
• A range of health insurance offerings.
• Competitive retirement planning offerings.
• Global Employee Assistance Programme.
• Life assurance.
• Flexible country-specific optional benefits.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless.