French-speaking Clinical Research Associate

Hlx Life Sciences; Milton Keynes; Presencial; GBP 65.000 - 101.000; A tiempo parcial

Descripción de la vacante

Hlx Life Sciences seeks an experienced Freelance CRA in the UK to support a sponsor-dedicated, part-time project. The role involves monitoring sites across international studies, with a preference for prior France-site experience and fluency in French and English.

You will conduct site initiation, routine monitoring, and close-out visits, manage relationships with investigators, monitor study metrics, and ensure compliance with ICH-GCP and local regulations.

Formación

• Strong independent CRA and site monitoring experience.
• Fluent in French and English.
• UK based with ability to travel for site visits.
• Experience on global/multinational clinical trials.
• Experience monitoring or supporting sites in France preferred.
• Comfortable working across international cross-functional study teams.
• Strong knowledge of ICH-GCP and clinical trial regulations.
• Oncology, Rare Disease and/or Neurology experience preferred.

Responsabilidades

• Managing monitoring activities across assigned clinical trial sites
• Conducting site initiation, routine monitoring and close-out visits
• Managing site relationships and acting as a key point of contact for investigators and site teams
• Monitoring recruitment, data quality, site performance and key study metrics
• Identifying and escalating site-level risks and supporting resolution of study issues
• Ensuring compliance with the protocol, ICH-GCP and applicable local regulations
• Reviewing source documentation, study documentation and site files
• Supporting study start-up and site activation activities where required
• Completing monitoring reports and study documentation within agreed timelines

Conocimientos

CRA monitoring experience

French & English fluency

UK based with travel

Global/multinational trials

ICH-GCP knowledge

Descripción del empleo

Freelance CRA – UK | French & English Speaking

I’m currently supporting a CRO looking to bring an experienced Freelance CRA onto a part-time, sponsor-dedicated project.

The CRA will be based in the UK and work closely with both the CRO and sponsor teams, supporting sites as part of a global clinical trial. We’re particularly interested in CRAs who have experience working across international studies and ideally have previously supported sites in France.

Key responsibilities:

• Managing monitoring activities across assigned clinical trial sites
• Conducting site initiation, routine monitoring and close-out visits
• Managing site relationships and acting as a key point of contact for investigators and site teams
• Monitoring recruitment, data quality, site performance and key study metrics
• Identifying and escalating site-level risks and supporting resolution of study issues
• Ensuring compliance with the protocol, ICH-GCP and applicable local regulations
• Reviewing source documentation, study documentation and site files
• Supporting study start-up and site activation activities where required
• Completing monitoring reports and study documentation within agreed timelines

Experience required:

• Strong independent CRA and site monitoring experience
• Fluent in French and English
• UK based with the ability to travel for site visits when required
• Experience working on global/multinational clinical trials
• Previous experience monitoring or supporting clinical trial sites in France would be ideal
• Comfortable working across international and cross-functional study teams
• Strong knowledge of ICH-GCP and clinical trial regulations
• Oncology, Rare Disease and/or Neurology experience preferred

Contract details:

• Freelance / contract
• Part-time
• UK based
• Global clinical trial
• Site travel required