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Lead CRA

  1. Kuala Lumpur
JR140740
  1. Clinical Monitoring
  2. ICON Strategic Solutions
  3. Remote

About the role

Lead CRA

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.

We are currently seeking a Lead Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.

  • Review and assessing site performance, including enrollment, data quality, and compliance
  • Identify risks and implement risk mitigation plans in collaboration with Clinical Operations
  • Serve as functional lead for assigned CRAs, including but not limited to:
  • Oversight of monitoring activities
  • Review of monitoring visit reports according to review strategy
  • Guidance on complex site issues and protocol deviations
  • Oversee site metrics and site challenges
  • Act as primary point of contact for any study monitoring related questions or concerns
  • Motivate investigators to achieve recruitment targets and implement initiatives to improve recruitment
  • Act as primary CRA for minimum 1 site to ensure they are familiar with the study/monitoring procedures
  • May host regular calls with CRAs to discuss site level KPIs as needed
  • Support onboarding, training, and mentoring of CRAs
  • Keep the Project Manager regularly informed
  • Partner with Clinical Project Managers, Medical Monitors, Data Management, Regulatory Affairs, and other stakeholders
  • Provide input into study timelines, monitoring activities and site/study level challenges
  • Participate in study team meetings and contribute to decision‑making
  • Ensure audit and inspection readiness at all times
  • Support internal audits, health authority inspections, and CAPA development
  • Oversight of handovers of sites between CRAs post allocation of CRAs
  • Promote a culture of quality, compliance, and continuous improvement
  • Participate in training and mentoring CRAs as appropriate
  • Conduct co-monitoring visits as needed to oversee the competencies and skills of the CRA
  • Responsible for the conduct/management of any aspect(s) of a project, when requested and authorized by project manager.

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. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

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