Lead CRA
Boost your chances before you apply.
ICON plc
Durham, NC, US
Summary
The Lead CRA is responsible for managing site activities including selection, initiation, monitoring, and close-out to ensure protocol and regulatory compliance. They also serve as the primary contact for clinical sites, mentor junior CRAs, and collaborate with cross-functional teams to ensure successful trial execution.
Job Description
Lead CRA
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.
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 (will consider other 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
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Founded
2017
Company size
10,001+ employees
Industry
Healthcare Intelligence and Clinical Research
Org type
Public Company
Headquarters
Dublin
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Founded
2017
Company size
10,001+ employees
Industry
Healthcare Intelligence and Clinical Research
Org type
Public Company
Headquarters
Dublin