Principal Clinical Research Associate
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Job Description
Principal Clinical Research Associate overseeing clinical trial sites and CRA teams for ICON Strategic Solutions. Ensuring compliant study execution, risk management, and participant safety.
Responsibilities:
- Oversee and manage clinical trial sites
- Coordinate clinical trial monitoring delivery
- Resolve study issues and support CRA team performance
- Ensure studies comply with regulatory requirements, study protocols, and company standards
- Perform site qualification, initiation, monitoring, and closeout activities
- 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 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
Requirements:
- 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
- Ophthalmology experience, particularly retina and/or wet AMD studies
- Experience supporting masked and unmasked clinical trials
- Prior biotech experience
- Willingness to travel as required (approximately 60%)
- Legal right to work in the country where the role is based
Benefits:
- 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
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