Related skills
gcp informed consent site monitoring regulatory submissions ctms๐ Description
- Oversees all aspects of study site management to protect patient safety and data quality.
- Serves as primary site contact and ensures adherence to ICH-GCP and SOPs.
- Manages trial tools, status reports, and monitoring documentation.
- Conducts site visits (pre-study, initiation, routine, close-out) with timely reports.
- Coordinates site startup activities: feasibility, IRB submissions, and consent.
- Travels 60-70% to support global studies and IP handling.
๐ฏ Requirements
- Bachelor's degree or international equivalent in science or healthcare.
- Minimum 2 years of on-site CRAII monitoring; oncology/Phase I preferred.
- Strong knowledge of ICH-GCP, GPP, SOPs, and regulatory guidance.
- Proficiency with Microsoft Office; fluent in English (verbal and written).
- Ability to travel 60-70% and work independently in a remote environment.
- Excellent organizational, communication, and data quality focus.
๐ Benefits
- We are an Equal Opportunity Employer.
- Growing organization serving cancer therapies.
- Remote-friendly environment with cross-functional teams.
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