Clinical Coordinator

Company Information

Advent Bioservices is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated using advanced therapy medicinal products. We currently manufacture in aseptic suites in London and at our newly licenced facility in Sawston, Cambridge.

Job Summary

We are looking for an experienced and proactive Clinical Coordinator to progress their career with us in the exciting area of cell and gene therapies.

We are seeking someone with excellent written and verbal communications skills and exceptional people skills who wants to work in a supportive, fast-paced environment to effectively coordinate and sensitively communicate with clients, Pathology Laboratories, Apheresis departments and any other departments in hospitals worldwide. As Clinical Coordinator you will work closely with staff across the company to coordinate the efficient delivery of cellular therapy products for clinical use, in accordance with HTA and MHRA regulations.

Key responsibilities for this role include:

- Acting as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
- Working with the manufacturing and quality team to ensure that the procurement, manufacture, transportation and storage of tissue and cells is compliant with HTA and MHRA regulations.
- Ensuring that contracts with all relevant stakeholders required for the manufacture of ATMPs and storage of external clients samples are in place, such as SLAs and MTAs.
- Writing and reviewing documents such as policies and forms related to scheduling and coordination of cellular therapy products for manufacture, and receipt, storage and distribution of external clients samples.
- Communicate with the clinician to ensure documentation is completed correctly and in a timely manner and to schedule administration of product.
- Ensuring that required Infectious Disease Markers and any other clinician-advised lab studies are completed and available as per HTA guidelinesReporting of adverse events and reactions in line with company policy and HTA regulations.
- Scheduling manufacturing slots with the manufacturing team to allow them to manage their workload effectively.
- Ensuring quotes/ proposals are sent out in a timely mannerThorough and accurate completion of all necessary paperwork.

You will have the following experience/qualifications:

- Demonstrable experience of working in an administrative post and preferably coordinating clinical activities.
- Excellent understanding of General Data Protection Regulations (GDPR) and confidentiality.
- Excellent IT Skills, including Microsoft office programs.

We offer excellent opportunities for career progression along with training and the chance to be a part of a growing organisation. We also offer an attractive base salary and benefits package.