About the Role

Submission & Amendment Support: Assist with initial and ongoing submissions, including amendments to ethics committees.
Regulatory Reporting: Manage periodic reporting to ethics committees, including the reporting of safety events.
Pre-activation & SIV Support: Contribute to site pre-activation activities and support Site Initiation Visits (SIVs).
Monitoring & Site Management: Conduct both onsite monitoring and periodic central monitoring to ensure trial integrity; manage site relationships and processes.
Documentation & Closeout: Maintain the eTMF (electronic Trial Master File) and lead closeout visits, ensuring compliance and completeness.

Qualifications

Experience: Minimum of 5 years of clinical monitoring experience within a CRO, biotech, or pharmaceutical environment.
Education: A Bachelor's degree in a related field (Life Sciences, Nursing, etc.).
Regulatory Knowledge: Strong understanding of ICH-GCP guidelines and regulatory requirements in the UK.
Technical Skills: Proficiency in clinical trial management systems (CTMS) and eTMF platforms.
Communication: Excellent written and verbal communication skills with the ability to interact effectively with site staff and sponsor representatives.