Senior Clinical Trials Assistant

Job overview

Are you looking for a rewarding career in Research?

We are delighted to be offering a full time/part time post, to suitable candidates wishing to start or develop their skills and practice in Clinical Research.

We have a team of around 54 staff including Research Nurses, AHP's, Research Governance and Research Administrative staff, working together to ensure that research is considered as part of patient care options for all eligible patients and ensure that research opportunities are available to our patients.

Working in Clinical Research, you will join an enthusiastic, driven, and caring research team, to help provide support to our research team, for new and existing studies. Our team participates in research within many different specialities across the Trust. There are always opportunities to gain knowledge and experience within a number of these specialities. Clinical research experience is not essential for the role, full research training will be given; we have an excellent induction and ongoing education programme.

Main duties of the job

To support the safe conduct of research in accordance with the Research Governance Framework, for clinical trials in accordance with the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines/EU Directive to provide assurance that the rights, safety and wellbeing of trial participants are protected

To provide comprehensive clinical/administrative support and data management for all aspects of trial organisation, as an integrated member of the research team

To support the line management and supervision of the clinical trials assistant team

To ensure the CTA team job plans are maintained and capacity to support the research team is prioritised as directed by the lead research nurse.

The post holder will be expected to interact with patients and their families in relation to the clinical trial and be able to work without supervision

Job responsibilities

Administrative

In collaboration with the research team ensure clinical study/trial site files are maintained according to regulatory and standard operating procedure requirements. Be responsible for complex data collection and transcribe complex information to Case Report Forms, for a specific portfolio of studies as per Good Clinical Research Practice guidelines (GCP). Able to receive, handle, analyse and resolve data queries promptly, and direct unresolved/clinical queries to appropriate team members. Be able to respond to patients/carers telephone calls (who may at some times be distressed) tactfully and empathetically. To reassure patients/carers regarding arrangements made. To contribute to writing departmental standard operating procedures and ensure implementation within the research team. Initiate and assist with planning, setting up, and opening to recruitment of clinical trials, monitoring visits, closing to recruitment of trials and archiving. To develop, implement and maintain accurate data systems in accordance with strict protocol guidelines. Undertake accurate data entry using computerised and/or paper based systems. To maintain the confidentiality of the Trust in respect of patient and staff information obtained at all times, and use such information only as authorised for specific purposes.

Patient Support

To assist in the identification of patient eligibility for studies/trials. Liaise with other appropriate health care professionals Co-ordination of pre-study tests, obtaining results/X-Rays and arranging appropriate appointments as per clinical trial protocols To assist with the co-ordination of the patients journey through the clinical trial protocol e.g. requisition and organisation of any necessary investigations. Provide clinical support, if required, during patient study visits.

Personal/Line Management Responsibilities

Organise research/trial monitor sessions ensuring that both the case report forms and the patient notes are prepared in advance. Ensure personal and other admin team(s) job plans are up to date and reflect the priorities with in the research team. Under supervision from Lead Research Nurse, act as line manager for other clinical trials assistants. Contributing to appraisals, 1:1s and ensuring mandatory training is completed. Chair monthly Administration / Clerical meetings, set the agenda and take an active part in these meetings. To report any accident, untoward incident or loss relating to staff, patients or visitors according to Trust policies. To undertake in-service training relevant to the post. Comply with Trust Policies and Procedures.

Administrative

In collaboration with the research team ensure clinical study/trial site files are maintained according to regulatory and standard operating procedure requirements. Be responsible for complex data collection and transcribe complex information to Case Report Forms, for a specific portfolio of studies as per Good Clinical Research Practice guidelines (GCP). Able to receive, handle, analyse and resolve data queries promptly, and direct unresolved/clinical queries to appropriate team members. Be able to respond to patients/carers telephone calls (who may at some times be distressed) tactfully and empathetically. To reassure patients/carers regarding arrangements made. To contribute to writing departmental standard operating procedures and ensure implementation within the research team. Initiate and assist with planning, setting up, and opening to recruitment of clinical trials, monitoring visits, closing to recruitment of trials and archiving. To develop, implement and maintain accurate data systems in accordance with strict protocol guidelines. Undertake accurate data entry using computerised and/or paper based systems. To maintain the confidentiality of the Trust in respect of patient and staff information obtained at all times, and use such information only as authorised for specific purposes.

Patient Support

To assist in the identification of patient eligibility for studies/trials. Liaise with other appropriate health care professionals Co-ordination of pre-study tests, obtaining results/X-Rays and arranging appropriate appointments as per clinical trial protocols To assist with the co-ordination of the patients journey through the clinical trial protocol e.g. requisition and organisation of any necessary investigations. Provide clinical support, if required, during patient study visits.

Personal/Line Management Responsibilities

Organise research/trial monitor sessions ensuring that both the case report forms and the patient notes are prepared in advance. Ensure personal and other admin team(s) job plans are up to date and reflect the priorities with in the research team. Under supervision from Lead Research Nurse, act as line manager for other clinical trials assistants. Contributing to appraisals, 1:1s and ensuring mandatory training is completed. Chair monthly Administration / Clerical meetings, set the agenda and take an active part in these meetings. To report any accident, untoward incident or loss relating to staff, patients or visitors according to Trust policies. To undertake in-service training relevant to the post. Comply with Trust Policies and Procedures.