Lead CRA

 Posted 3 hours ago
     
⭐ 5-10 years experience
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AI Summary

The Lead CRA oversees clinical trial sites to ensure compliance with regulatory requirements, study protocols, and company standards. They are responsible for driving site performance, mentoring other CRAs, and ensuring high data quality and patient safety.
Lead CRA

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


We are currently seeking a Lead Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Lead CRA at ICON, you will play a pivotal role in overseeing and managing clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards. You will be a key contributor to the success of clinical trials by driving site performance, providing mentorship to CRAs, and ensuring the highest levels of data quality and patient safety.

What You Will Be Doing:

  • Leading site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines.

  • Serving as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance.

  • Ensuring the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations.

  • Mentoring and providing guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies.

  • Collaborating with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials.

Your Profile:

  • Bachelor's degree in life sciences, nursing, pharmacy, or a related field. Advanced degree preferred.

  • Extensive experience as a Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials.

  • In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.

  • Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively.

  • Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues.

  • Experience in Gene Therapy or Ophthalmology studies (complex indications)


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • 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

Benefits may vary depending on role and location.


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


Inclusion and Accessibility

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.

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

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