Overview
In this role you will monitor clinical studies across investigative sites, ensuring adherence to protocol, SOPs, ICH-GCP, and applicable regulations. You will coordinate study setup and monitoring activities, including investigator identification and regulatory submissions. You will work remotely from the UK or Northern Ireland, with a travel requirement; the environment emphasizes support from leadership and the opportunity to influence outcomes in a smaller CRO. You will develop deep expertise in protocols and contribute to oncology and precision medicine trials that shape patient care.
Responsibilities
- Monitor progress of clinical studies at investigative sites and ensure conduct, recording and reporting per protocol, SOPs, ICH-GCP, and regulations
- Coordinate setup and monitoring activities, including identifying investigators and assisting with regulatory submissions
- Conduct pre-study and initiation visits and support project teams with site readiness and ongoing study management
Key requirements
- 4-year college degree or equivalent experience
- 1+ years CRA experience in CRO or pharmaceutical industry
- Oncology experience and early phase experience desirable but not essential
- Travel availability up to 50-60% domestically (some senior roles may include international travel)
- Fluency in English
- calm
- thoughtful
- responsive
- ICH-GCP compliance
- regulatory submissions support
- site monitoring and study coordination
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