CRA II / Senior CRA
IRE
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- Location
- Sydney, NSW
- Type
- Full-time
About the role
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 CRA II at ICON, you will perform site qualification, initiation, monitoring and closeout activities as assigned.
What You Will Do:
You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively.
Key responsibilities include:
- 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%).
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
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