Overview
Part-time (0.5 WTE) Clinical Trials Coordinator position for a 6-month contract. The post holder will assist in providing a clinical research service for a portfolio of national and local, including RDN-adopted, clinical trials undertaken at King's College Hospital NHS Foundation Trust within the Orthopaedic department. The focus of the work will be on portfolio adopted studies, non-commercial and commercial, to be decided after liaison with the Trauma & Orthopaedic R&D lead and Orthopaedic Research Governance and Feasibility (RGF). The post holder will also be involved in follow-up and completion of relevant trial-specific paperwork and in coordinating patient activity at all stages of the research pathway.
Responsibilities
- Coordinate patient activity and oversee patient care at all stages of the research pathway.
- Data management: collect data, enter data and resolve discrepancies; provide data support to clinical research organisations and sponsors to satisfy audit and monitoring requirements.
- Support investigators and their teams at recruiting sites for multi-centre trials sponsored by KCH.
- Work with multidisciplinary team (Investigators, Research Manager, clinicians, Research Governance and pharmacy).
- Ensure all relevant documents and approvals are in place at each site prior to subject recruitment.
- Identify patients suitable for entry into clinical trials by attending clinics, MDT meetings, and screening electronic and paper notes.
- Ensure patients are fully informed prior to entry in any clinical trial programme; assist in consenting, randomising, and allocation of treatment where applicable.
- Evaluate patient eligibility by coordinating pre-study tests, obtaining results, and arranging appropriate appointments per protocol.
- Coordinate ongoing study visits and investigations as per the protocol.
- Explain practical aspects of clinical trials to patients and their relatives; provide patient and relative support as needed.
- Coordinate collection of biological samples and ensure safe storage of specimens.
- Maintain accurate patient records and ensure documentation in medical notes; ensure timely completion of Case Report Forms (CRFs).
- Manage data coordination and computerisation of trial data; provide signposting to support as appropriate.
- Assist in reviewing trial protocols and identify resource implications for the site; liaise with medical team/sponsor on on-study treatment and follow-up.
- Assist with recording and reporting of SAEs and incidents per protocol and sponsor SOPs.
- Upload accrual data onto the EDGE database (Trust’s clinical trial management system).
- Support information collection for invoicing where appropriate; liaise with other departments to raise awareness of current trials.
- Participate in presenting research findings within the Research Delivery Network and to external agencies as appropriate.
- Report adverse incidents and near misses via the Trust’s online incident reporting system.
- Adhere to GCP principles as set out in Clinical Trials Regulations; stay up to date with cannulation, phlebotomy, and care of patients with Central Venous Access lines.
- Any other duties of a similar nature as requested by the RDU Managers and supervisors.
About the Trust and Context
King’s College Hospital NHS Foundation Trust is one of the UK’s largest and busiest teaching Trusts with a broad portfolio across five sites in South East London. The Trust provides a full range of local hospital services and specialist services from its King’s sites, and is committed to the Green Plan and Sustainable Healthcare.
Requirements and Expectations
At all times, adhere to the principles of Good Clinical Practice (GCP) as set out in the Clinical Trials Regulations. Keep up to date with current practices relevant to cannulation, phlebotomy, and care of patients with Central Venous Access lines.