Clinical Research Associate II
On-siteDublin, Leinster, Ireland
Job Summary
Conduct site monitoring visits for interventional studies, covering selection, initiation, monitoring, and close-out in adherence to GCP and ICH guidelines. Adapt and track subject recruitment plans to enhance predictability while administering protocol training to assigned sites. Evaluate site practices for proper conduct and escalate quality issues as appropriate. Manage study progress by tracking regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution. Maintain site documents for the Trial Master File and Investigator's Site File, submitting regular visit reports and follow-up letters. Requires at least two years of on-site monitoring experience; this role is not eligible for visa sponsorship.
Required Qualifications
- At least 2 years on-site monitoring experience of interventional studies
- Degree in scientific discipline or health care or equivalent industry experience
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Ability to establish and maintain effective working relationships with coworkers and clients
- This position is not eligible for visa sponsorship
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