Description
As a Clinical Research Associate II at ICON Strategic Solutions, you will perform site qualification, initiation, monitoring and closeout activities as assigned.
You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively.
Key Responsibilities:
- Perform site qualification, initiation, monitoring and closeout activities as assigned.
- Verify protocol, GCP and regulatory compliance and participant protection.
- Review source data, essential documents and site processes for accuracy and completeness.
- Identify and follow up findings, risks and corrective actions.
- Maintain clear communication with investigators, site staff and study teams.
Required Qualifications and Experience:
- Relevant life sciences, healthcare or clinical research qualification, or equivalent relevant clinical research experience.
- Minimum of 2 years of experience as a Clinical Research Associate.
- In-depth knowledge of clinical trial processes, regulations, and ICH Good Clinical Practice (GCP) guidelines.
- Knowledge of ICH Good Clinical Practice (GCP), clinical trial conduct and site monitoring requirements.
- Practical experience with site monitoring or site management appropriate to the level of role.
- Experience performing site qualification, initiation, monitoring and closeout activities as assigned.
- Experience verifying protocol, GCP and regulatory compliance and participant protection.
Preferred Qualifications and Experience:
- Therapeutic area expertise relevant to assigned studies.
- Experience with risk-based monitoring or centralised monitoring approaches.
- Experience with clinical trial management systems (CTMS), electronic data capture (EDC) and electronic trial master file systems.
Working Conditions:
- Willingness to travel as required (approximately 60%).
Rewards & 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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