Lead Clinical Research Associate-Ophthalmology
ICON Strategic Solutions, Chicago, IL, United States
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
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
Lead CRA - Ophthalmology or Gene Therapy
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, organisational, and problem‑solving skills, with a proactive approach to managing site performance and resolving issues.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
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.
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.
#J-18808-Ljbffr
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
Lead CRA - Ophthalmology or Gene Therapy
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, organisational, and problem‑solving skills, with a proactive approach to managing site performance and resolving issues.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
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.
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.
#J-18808-Ljbffr