Lead Clinical Research Associate - Remote
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%).
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.
