Clinical Research Associate jobs in United Kingdom

hVIVO are currently looking for a proactive and experienced Research Scientist (RS) to join our laboratory team across our sites in E1 & E14. The RS position is a key role within lab operations and is critical in assisting in the delivery of clinical trials.

The hVIVO Laboratory function undertakes the sample processing and analysis for all clinical trials conducted at hVIVO. The RS position exposes applicants to a range of practical techniques including Qualitative and Quantitative PCR, cell infectivity, neutralising antibody, serology assays and multiplex viral detection assays. The laboratory division has a diverse work stream including internal studies, clinical trials and standalone projects. The laboratory division also performs bespoke assay development and validation work and collaborates with strategic partners.

The RS will work as part of our Laboratory Operations Department supporting the delivery of clinical trials. The wider team includes individuals with a wide range of experience including Research Assistants, specialists in specific areas and Senior Virologists.

The RS role is a lab focused position with room to develop and refine practical laboratory skills. The day to day work includes processing samples, performing assays and analysing data. The role offers significant growth as the position also requires leading projects (internal and external) by acting as Study Lead (SL). The SL is responsible for the smooth day to day running of the analytical phase of clinical trials performed at hVIVO, working under the guidance of a senior scientist. This gives applicants exposure to the responsibility and skills required for future project management positions. The SL role includes study resource management, matrix management of colleagues, and responsibility for data review and quality, sample logistics, document writing and delivery of training.

The role involves working to a flexible shift pattern including working evenings and weekend as required to deliver the operational plan.

The ideal candidate will have a virology / biomedical background, and have experience working to GCP / GLP as part of a CRO or pharmaceutical company. They will be degree educated or above and have hands-on experience of key virology techniques including tissue culture, cell-based infectivity assays and qPCR. They will be a proactive individual with a desire to learn and progress in a GCP environment. The candidate will be flexible with working patterns to suit the needs of the business.

• Performing sample processing and analysis in accordance with project and quality documentation, with a high degree of independence.
• Have a good working knowledge of current assays used in the field of virology;
• Make recommendations for the performance of scientific experiments in project areas.
• Maintaining sample integrity by following sample storage procedures.
• Follow all the applicable Policies, Standard Operating Procedures (SOPs), Study documentation and GCP and any other applicable guidelines.
• Work as a member of a team.
• Responsible for organising own time and resources in an optimal fashion, with some guidance;
• Proactively review the schedule and ensure that all assigned tasks are completed, flagging any issues to the Laboratory Operations Manager.
• Responsible for the delivery of GCP compliant study data for the samples being processed or assayed.
• Assist with storage and tracking of samples, develop an understanding of HTA legislation.
• Conduct projects according to the agreed protocol and timeline in line with GCP standards.
• Develop project documentation and services, in line with client requirements.
• Support senior members of staff in the planning and delivery of clinical projects.

• Previous experience working to GCP / GLP standards, minimum 3 years full time
• Experience working within a CRO or pharmaceutical company
• Experience working within a virology or biomedical lab
• 1st Degree in relevant scientific subject (2 : 1 or above preferable) or equivalent

• Understanding of HTA regulations
• Project management experience
• Understanding of the clinical aspects of delivering GCP projects.