Principal Clinical Research Associate
Icon Plc
·Today
- Location
- US, Blue Bell (ICON), United States of America
- Workplace
- Remote
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Lead
- Source
- Workday
Description
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.
As a Principal CRA at ICON, you will oversee and manage clinical trial sites, ensuring studies are conducted in accordance with regulatory requirements, study protocols, and company standards.
What You Will Do:
Your focus will be on coordinating clinical trial monitoring delivery, resolving issues, supporting CRA team performance, and ensuring successful study execution in a fast-paced environment.
Key Responsibilities
- Perform site qualification, initiation, monitoring, and closeout activities as assigned.
- Verify protocol, GCP, and regulatory compliance while ensuring participant safety and data integrity.
- Identify, communicate, and follow up on study findings, risks, and corrective actions.
- Maintain effective communication with investigators, site staff, and study teams.
- Review monitoring activities and provide guidance, coaching, and support to CRA team members.
- Support study execution through proactive risk management, issue resolution, and operational oversight.
Required Qualifications and Experience
- Proven Lead CRA experience providing oversight, coaching, and mentoring to CRA teams.
- Experience reviewing monitoring reports, ensuring quality standards, and driving follow-up of action items.
- Demonstrated ability to identify, assess, and escalate study risks while applying strong clinical judgment.
- Experience working directly with stakeholders in an FSP and/or biotech environment.
- Strong adaptability and ability to execute within evolving processes and changing priorities.
- Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial operations.
- Relevant life sciences, healthcare, or clinical research qualification, or equivalent industry experience.
Please note: This position is intended for experienced Lead CRAs and is not suited for Senior CRAs seeking their first Lead CRA opportunity.
Preferred Qualifications and Experience:
- Ophthalmology experience, particularly retina and/or wet AMD studies.
- Experience supporting masked and unmasked clinical trials.
- Prior biotech experience.
Working Conditions:
Willingness to travel as required (approximately 60%).
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