Clinical Research Associate
Home Based, United Kingdom
To reinforce our Clinical Development Business unit, Clinical Operations department, we are looking for an experienced Home-Based CRA for UK.
- Ensuring all aspects of study site monitoring visits both covering United Kingdom sites (selection, initiation, monitoring and close-out) according to Keyrus Biopharma or Client SOPs;
- Writing of study site visit reports;
- Maintenance of study files and administrative follow-up of studies according to GCP-ICH;
- Participation in the preparation of submissions to ECs;
- Ensuring, in compliance with GCP and SOPs, the quality, reliability and authenticity of data collected during monitoring;
- Review clinical sites progress and initiate appropriate actions to achieve target recruitment objectives.
- University Scientific Degree, Master: Biology, Bio Medical Sciences, Bio Engineer or equivalent by experience;
- Good knowledge ICH-GCP/GMP and regulatory requirements;
- Attention to detail;
- Analytical and organized;
- Good interpersonal skills;
- Good oral and written communication;
- Native English Speaker, other European language is a plus.
Required work experience in this role
- 2-3 years experience in a pharmaceutical company or CRO with experience of clinical monitoring.