Job Description
Oslo, Norway | Full time | Home-based | R
We are seeking an **experienced Compliance Clinical Trials Assistant** to join our **cFSP (sponsor-dedicated) team in EMEA.**
**Key Responsibilities**
- Document oversight - managing and organising essential trial documents (e.g., Trial Master File / TMF)
- Regulatory compliance support - ensuring studies follow guidelines like GCP (Good Clinical Practice), SOPs, and regulatory requirements
- Audit and inspection readiness - supporting preparation for audits or inspections from regulators (e.g., MHRA, FDA)
- Tracking and reporting - monitoring compliance metrics, deviations, and quality issues
- Process improvement - identifying gaps and helping improve compliance processes
**What We’re Looking For**
- Previous compliance experience within clinical trials required.
- Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (...
We are seeking an **experienced Compliance Clinical Trials Assistant** to join our **cFSP (sponsor-dedicated) team in EMEA.**
**Key Responsibilities**
- Document oversight - managing and organising essential trial documents (e.g., Trial Master File / TMF)
- Regulatory compliance support - ensuring studies follow guidelines like GCP (Good Clinical Practice), SOPs, and regulatory requirements
- Audit and inspection readiness - supporting preparation for audits or inspections from regulators (e.g., MHRA, FDA)
- Tracking and reporting - monitoring compliance metrics, deviations, and quality issues
- Process improvement - identifying gaps and helping improve compliance processes
**What We’re Looking For**
- Previous compliance experience within clinical trials required.
- Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (...
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