Senior Clinical Trials Assistant

JOB SUMMARY To provide clinical trial support for clinical trial activities in LHCH Research Department. PRINCIPAL ACCOUNTABILITIES Research - Complete all delegated tasks for research studies in line with GCP and trial protocols. - Assess patients eligibility for recruitment to delegated studies in accordance with trial Protocol. - Ensure all trial paperwork is accurately completed, including transcribing/exporting data from medical records/hospital IT systems to Case Report Forms (CRFs) (paper or electronic) as required by clinical trial protocols, checking eligibility of patients for entry into trials and randomising/registering patients into trials according to protocol requirements.
- Ensure timely submission of accurate and completed CRFs to the Trial Coordinating Offices, responding to data queries as necessary. - Ensure clinic appointments/tests required for patients involved in trials are carried out according to the schedule in the protocol. - Assist in the care and follow up of clinical trial patients. Where appropriate and for specific trials, the postholder may be expected to work autonomously obtaining patient informed consent to participate in a study, provide information, education and support to patients on clinical trials.
- Provide general administrative support to cancer clinical trials, including filing, typing, fielding telephone calls, ordering patient notes and retrieving patient test results via hospital IT systems. - Update the oncology trials database with details of patients screened and recruited to trials onto clinical trials. - Make arrangements for pathological samples, radiological films and electronic data to be sent for central review. - Act as first telephone contact for enquiries about cancer trials.
- Support the LHCH team in preparing trial documentation for monitoring visits. - Maintain close links with the wider LHCH and attend LHCH staff meetings. - Ensure trials are carried out according to ICH-GCP, the EU Directive on Good Clinical Practice and the Research Governance Guidelines. - Undertake clinical observations as required by study protocol, to include venesection, obtaining blood pressure (manual or electronic), recording ECGs and measuring height and weight.

Training will be provided where necessary. PROFESSIONAL - Develop a sound knowledge of clinical cancer research in the relevant disease specialities. - Develop a sound knowledge of ethics related to research. - Where appropriate, undergo training in aspects of clinical trials and clinical trial administration, including ICH GCP, data collection, and completion of Case Report Forms.

QUALITY -Acts consistently with policies, procedures and clinical guidelines and encourages others to do so. -Ensure due regard is given to customs, values and spiritual beliefs of patients and equality and diversity is always upheld. - Be diligent and obtain high quality data. - Ensure patients receive the best care throughout their involvement within a study.

GENERAL STATEMENTS CONFIDENTIALITY All employees must adhere to policies and procedures relating to Information Governance, Confidentiality, and Information Security. RISK MANAGEMENT The Trust is committed to approaching the control of risks in a strategic and organised manner. The postholder must be aware of their individual responsibilities as detailed in the Trusts Risk Management, Health & Safety and Incident policies, and those under the Health and Safety at Work Act. This includes the reporting of any untoward incident, accident, potential or actual hazard identified.

SAFEGUARDING All staff are required to be familiar with the arrangements for safeguarding children, young people and vulnerable adults and support the organisation in promoting the welfare of children, young people, and vulnerable adults. Staff working directly with children, young people and vulnerable adults will have a responsibility to ensure safeguarding and promoting their welfare forms an integral part of their duties. Staff who come into contact with children, vulnerable adults, parents and carers in the course of their work and/or have access to records will have responsibilities to safeguard and promote the welfare of children, young people and vulnerable adults. Staff who come into contact in the course of their duties, with parents, carers or other significant adults or children, young people and vulnerable adults should always be mindful of safeguarding and promotion of the welfare of these individuals.

INFECTION CONTROL In accordance with the Health and Social Care Act 2008, it is the responsibility of every member of staff to participate in the prevention and control of infection within the capacity of their role. In order to maintain high standards of infection and prevention control all staff are expected to comply with the relevant Trust policies, procedures and guidelines and report any concerns to their manager or to the infection prevention team. HEALTH AND WELLBEING The Trust