Senior/Clinical Research Associate
PrecisionMedicineGroupRemotely
monitoringipedctmfich gcpgppsae
Job Description
📋 Description
- Supports study sites and clinical project teams in clinical research studies.
- Ensures adherence to protocols, SOPs, ICH-GCP, GPP, and country regulations.
- Conducts site visits (pre-study, initiation, routine, close-out) and remote monitoring.
- Manages trial tools, status reports, and site/start-up activities when needed.
- Oversees patient safety, data quality, IP handling, and SAE reporting.
🎯 Requirements
- Bachelor's degree or international equivalent; 3+ years on-site monitoring; oncology/Phase I
- Strong knowledge of ICH-GCP, regulatory guidance, and SOPs.
- Excellent organizational skills; fluent English; capable of remote work.
- Travel 60-70% as required; solid data management and communication skills.
- Experience with IP inventory, ISF/TMF reconciliation, and EDC data review.
- Preferred: clinical research experience and familiarity with budget/contract processes.
🎁 Benefits
- Opportunity to contribute to cancer therapies with a growing CRO.
- Collaborative environment and opportunities for professional development.
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