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Clinical Research Trials Assistant - job post

South West London and St Georges Mental Health NHS Trust
3.6 out of 5 stars
Tooting SW17 7DJ
£37,259 - £45,356 a year - Fixed term contract

Location

Tooting SW17 7DJ

Full job description

Core Responsibilities Develop knowledge of the ethical principles for clinical research and its implications for current practice. As a member of the R&D team, s/he will be responsible for the provision of robust operational support in all aspects of clinical trials administration according to Good Clinical Practice (GCP) guidelines, local standard operating procedures (SOPs) and other relevant SWLStG policies. Be responsible for his/her own personal and professional development, ensuring that all relevant skills and training (e.g. GCP) remaining up-to-date to carry out all job-related responsibilities.

Help to identify mental health service users and carers who are eligible to take part in a range of research projects and to provide information and support for users involved in research projects. Responsible for collecting data, which will involve interviewing, supporting and monitoring patients, and working closely with the Research Unit Coordinator and the Data Analyst to facilitate the unit. Recruit patients to observational trials, and participate in the follow-up and completion of relevant trial-specific paperwork. Post holder will ensure that patients care and treatment, assessments, follow-up and data collection are conducted according to the appropriate research protocols.

This will involve close liaison with mental health, social care and primary care services including both psychiatric units and community settings. Clinical Responsibilities Ensure the well-being of study participants as the primary concern of research practice. Support the recruitment of participants into the clinical studies. To become patients guide and advocate through the decision-making process, enabling patients to articulate reasons for trial participation or refusal, and helping patients to deal with the uncertainties of trial participation.

To continually use judgement skills to assess patients suitability for trial participation and advising their Consultants/care coordinators of suitability. Ensure that the procedures of consenting are followed as these are vulnerable patient population. This will include informing patients/carers/next of kin regarding research methods, results and their interpretation, treatment decisions and adherence to medications. To keep up to date with developments in research practice and to ensure that such practice throughout the Trust is in keeping with current legislation and guidance.

Carry out clinical assessments in line with specific eligibility criteria. Organise and manage defined procedures, assist with intervention treatments and collect/record data arising from these. To undertake training in psychometric assessments and monitor trials procedures. Research Responsibilities To exercise professional judgement and knowledge of trial eligibility criteria when identifying suitable patients for clinical trials.

To register and randomise patients into clinical database. To take responsibility for accurate and complete data collection, updating and maintenance of databases and computerised systems. Creation of spread sheets for patient tracking. Ensuring corresponding documentation is recorded in medical notes.

To take responsibility for ensuring that trial protocols are adhered to by all members of the multi-disciplinary team, ensuring follow up appointments and tests required are ordered and arranged. Maintain the source data and case report forms and all other trail documents in a manner conducive to audit. Report adverse events following the study procedures, including the expedited reporting of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions. Will be responsible for the coordination investigations, collection of samples and ensure safe and appropriate storage of specimens as part of the clinical research protocol.

To play a key role in eliciting informed consent from service users and carers to participate in clinical trials. To take responsibility for the resolution of data queries, follow-ups and trial closedown. To participate in clinical audit and Research and Development activities including nurse-led research projects. Communication To support the Research Unit co-ordinator and the Head of the CRU-POAN in ensuring that effective communication systems are in place to facilitate the dissemination of research findings.

To work closely with the research team and the research stakeholders (internal and external), including Trust staff, other members of the multidisciplinary team, service users, carers, their families and the wider research community if necessary. Portfolio Management and professional Development To complete the mandatory Trust training and ensure that supervision is done within the timely manner. To complete the mandatory study training when required. To liaise with and assist the medical team/sponsor organisation in on-study treatment and follow-up of patients.

To support the administrative management of the CRU-POAN portfolio. To be accountable for own professional actions, work autonomously without direct supervision. To demonstrate specialised mental health site specific knowledge relevant to area of practice. To assume responsibility for continuous education by attending related workshops, seminars, conferences and courses as well as keeping up to date on current publications.

Developing the Service To support the development of the service by ensuring that the service users, their relatives and/or carers are empowered to be fully participative in research activity wherever possible. To contribute to the development and maintenance of Trust R&D standard operating procedures (SOPs).
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