Senior Clinical Trials Co-ordinator

5 months ago

Manchester, United Kingdom Greater Manchester Mental Health NHSFT Full time

Study set-up To act as a point of contact with study sponsor, Clinical Trials Units, Clinical Research Organisations, R&I and NIHR/ CRN Research Networks. To liaise with and assist the study team regarding Research Ethics, HRA, and other regulatory submissions and funding arrangements. To liaise with the line Manager, clinical trials team, and R&I finance team regarding feasibility and resource requirements of studies, after discussion with the lead investigator To liaise with the R&I to gain Trust R&I approval To liaise with NIHR LCRN for studies adopted to the portfolio. For multi-centre studies, to lead on study initiation at the study sites according to regulatory requirements, including training staff in specific requirements.

For co-ordination of multi-centre studies, to travel to other centres and undertake study related duties as required For multi-centre studies, to ensure, recruitment are at an acceptable level at each centre. Suggest and implement strategies for improving recruitment. To be responsible for setting-up, maintaining and participating in effective and efficient communication processes with all stakeholders To ensure Trial Steering Committees and Data Monitoring Committees are set up, and meetings organised as appropriate. To draft and assist in the development of trial documents such as Schedules of Investigations, Patient Information Sheets, Informed Consent Forms, GP letters, data sheets, Case Report Forms and Adverse Event forms To ensure the study team has the capacity to conduct the study within its current workload and activity Study Conduct To implement and carry out procedures to ensure the team is compliant with the principles of Good Clinical Practice, the UK Policy Framework for Health and Social Care Research and all regulatory legislation in their day to day practice.

In liaison with the research team, implement protocols to ensure that study specific investigations are carried out correctly and in a timely manner; scheduling patient follow-up visits and assessments (including those with other departments within the Trust, or as per study requirements) to ensure protocol compliance. To develop department and/or trial specific Standard Operating Procedures (SOPs) and Work Instructions where appropriate, ensuring they are revised and distributed as specified to the relevant teams. To ensure tissue and biomaterial collection and storage is implemented according to SOPs and liaise with the Trusts HTA licence manager regarding collection, storage and transfer of tissue samples when there are compliance queries. To keep abreast of Trust-wide research SOPs and policies and ensure the research team are aware and conducting research according to these SOPs and policies.

To ensure study Site/Master Files are maintained and kept inspection-ready at all times. To liaise with study investigators and nurses to obtain documentation on contact details, qualifications, CVs and other relevant documentation for study use. To ensure timely and efficient procedures for collection, electronic input and verification of all patient data, chasing of missing or incomplete data and raising queries as appropriate. To monitor data quality and to set up Quality Control procedures.

To process and communicate amendments according to GCP and Trust SOPs. To have the appropriate administrative processes in place to ensure, with the investigators, that Adverse Event and Incident forms are completed, reported and followed up to resolution as the study protocol and regulations require. To provide progress and other reports, as required, to all relevant parties; prepare presentations on behalf of the study team, and take part in study/team meetings. To communicate with the Trust Research Office, sponsors, funders, pharmaceutical companies, internal and external study personnel and outside agencies in a professional manner, maintaining an efficient flow of information to sustain smooth running of the study.

To ensure all study documents are archived according to sponsor and Trust requirements and SOPs/policies, and a formal retrieval system is in place within research team. To be proactive in monitoring working practices and suggesting improvements and new ways of working. Study delivery and targets To monitor performance within the research team. To ensure R&I targets for study set-up are achieved within agreed timeframes and resolve issues locally or escalated in a timely fashion to the line Manager.

To ensure R&I KPIs (Key Performance Indicators; including but not limited to time to recruit first patient, patient recruitment to time and target) are recorded in a timely and accurate manner. To inform the Principal Investigators (and R&I ) where there are problems or delays in recruiting patients, achieving targets or issues within the clinical trials team that will impact on the delivery of the proposed studies for the Trust. To initiate and lead on internal audits and robust risk management of study a

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