Overview
In this role you drive quality-driven clinical monitoring for investigator sites, ensuring studies run per protocol and regulatory standards. You work closely with sponsors and cross-functional teams, coordinating start-up, initiation visits, and regulatory submissions. You mentor junior staff and engage directly with clients on proposals and payments. This evergreen posting builds our pipeline for future opportunities in a highly collaborative, home-based environment in the UK and across Europe.
Responsibilities
- Monitor progress of clinical studies at investigative sites to ensure adherence to protocol, SOPs, ICH-GCP, and regulations
- Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and pre-study/initiation visits
- Support trials of varying scope and size, collaborating with cross-functional study teams
- Train and mentor junior staff members
- Engage with clients, initiate payments, and contribute to proposal activities and client presentations
Key requirements
- Minimum 5 years of CRA/SCRA experience in CRO, pharmaceutical, biotechnology, or medical device environments
- Experience monitoring clinical trials across multiple therapeutic areas
- Availability for domestic travel up to 50-60% (international travel may be required)
- Fluency in English and local language; additional languages a plus
- 4-year college degree or equivalent experience
- Holder of CRA certificate
- calm and thoughtful under pressure
- prepared and proactive
- attention to detail
- monitoring of clinical trials
- pre-study and initiation visits
- regulatory submissions
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