Research Coordinator

2 months ago

London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

The post holder will work within the Medical Specialties Directorate to cover administrative tasks within the research unit. The post holder will be responsible for assisting with the feasibility and set-up of trials, developing pathways, monitoring the quality of clinical trials and ensuring adherence to Research Governance requirements and ICH-GCP (Good Clinical Practice). The post holder will also be responsible for data management and administration of all studies in the unit with a willingness to work flexibly and across hospital sites.
- Liaison with R&D & KHP-CTO to ensure timely set-up, feasibility and logístical tasks of all Research
- Ensuring that the documentation to open research studies is produced in a timely and efficient manner.
- Data Management of trials which would include organisation of investigations, preparation of notes, tracking follow-up of patients, electronic data entry and regular submission of data to clinical trials centres.
- Providing advice to Investigators, Researchers and the Sponsor Companies on a range of R&D and Ethical issues.
- Maintaining a database and producing reports on accrual to research studies.

Guy’s & St Thomas NHS Foundation Trust Guy’s and St Thomas’ NHS Foundation Trust comprises five of the UK’s best known hospitals - Guy’s, St Thomas’, Evelina London Children’s Hospital, Royal Brompton and Harefield - as well as community services in Lambeth and Southwark, all with a long history of high quality care, clinical excellence, research and innovation.

We are among the UK’s busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark.

We have a long tradition of clinical and scientific achievement and - as part of King’s Health Partners - we are one of England’s eight academic health sciences centres, bringing together world-class clinical services, teaching and research. We have one of the National Institute for Health Research’s biomedical research centres, established with King’s College London in 2007, as well as dedicated clinical research facilities.

We have around 23,500 staff, making us one of the largest NHS Trusts in the country and one of the biggest employers locally.

We strive to recruit and retain the best staff as the dedication and skills of our employees lie at the heart of our organisation and ensure that our services are of the highest quality, safe and focused on our patients.

Clinical Trials/Research Administration
- Work with the Research Team to develop processes and systems to support research delivery
- Coordinate and complete submissions to R&D & KHP-CTO Departments which would include:

- Preparation of documentation when submitting trial protocols and paperwork to various committees and regulatory agencies for review and approval.
- Set-up of trials on site and organise trial set up visits which involves liaison with designated staff in radiotherapy, pharmacy and other support departments.
- Develop and maintain a system for monitoring/tracking the process of all submissions and ensure that all appropriate details on each submission is accurately reported and accessible by the Research Team
- Regular liaison with R&D & KHP-CTO#
- Liaise with Lead Investigators, Pharmacists, Research Nurses, Local Committees and other relevant personnel to ensure deadlines for R&D & KHP-CTO submission are met.
- Work with the appropriate researchers to manage the trials portfolio.
- Assist the Research Team with the preparation of the Annual Reports and documentation where requested.
- Attend all Team Meetings and provide reports on the status of all pending/proposed clinical trials in the unit.
- Work with the Research Team in developing systems for tracking trial income which would include raising invoices, providing income updates and notifying the Research Team of any discrepancies.
- Ensure all required documentation is kept and stored according to ICH Good Clinical Practice (GCP) and work with the Research Team in archiving clinical trials documentation as required.
- Disseminate information to consultants regarding new trials to enable optimal patient recruitment.
- Ordering of office/study supplies and equipment and maintenance of equipment including tracking of certificates for use

Data Management
- To collect data from patient medical records and complete Case Report Forms (CRFs) as required.
- Assist in reviewing and recording treatments, adverse events, toxicities and response to treatment.
- Organise the collection, storage and shipment of protocol specific samples.
- Liaise with designated Pharmacist to co-ordinate the availability and dispensing of trial drugs if required.
- Ensure that all clinical trial databases and logs are maintained which includes updating accrual data on a weekly basis.
- Ensure trial protocols are adhere

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