Key Working Relationships Internal Departmental colleagues Lead Research Nurse Head of Research Operations Research Management Team Research Delivery Teams Clinical Teams Support Departments External Patients and their relatives-carers-significant others Research Sponsor Organisations Clinical Trials Units -Universities Pharmaceutical companies - Contract Research Organisations NIHR Research Delivery Network Herefordshire and Worcestershire Research Consortium (HWRC) Partner Organisations Other External Research Teams Risk Assessment Manual handling activities Exposure to bodily fluids and exposure to high noise levels It may also involve exposure to challenging behaviour Works with display screen equipment for prolonged periods Job Purpose We are committed to supporting research that is relevant and accessible to our patients. Through clinical research we can assess the efficacy of new medication, diagnostics, and treatment regimes. This helps to build the evidence for new approaches to improve patient care The Clinical Trials Assistant will support the Research Delivery Team in the identification, recruitment and management of patients participating in research studies. The post-holder will help with data-collection, undertake specified clinical and laboratory tasks, and provide administrative support for research studies. The department is involved in a range of clinical studies including life changing oncology and haematology trials, internationally recognised midwifery, renal and surgical studies, and many more. You will have the opportunity to get involved with a range of these, having direct contact with patients, carers and staff. Key Duties Clinical Screen trust systems to identify patients who may be eligible for research studies Receive consent from patients into research studies, under direction, and with appropriate training, in accordance with GCP Randomise patients into different trial arms Organise patient appointments and book research-specific investigations and procedures Under supervision or after appropriate training, undertake clinical procedures required for research studies, including but not limited to; blood pressure recording, heart and respiratory rate, height, weight and BMI assessment, collection of blood and urine samples, measurement of hip-waist circumference Report all findings from clinical procedures to the research delivery team, and accurately document as advised by the team in appropriate patient records, research files, logs, CRFs and databases Provide ongoing assessment of participants clinical condition liaising with relevant clinicians as appropriate, e.g. if patient condition alters Process research participant samples according to clinical trial protocols such as processing of blood samples, preparing samples for storage or shipment, and arranging couriers for safe and timely transport of research samples Collect prescriptions and liaise with pharmacy to coordinate trial medication Explain and distribute research participant questionnaires, diaries and the NIHR Participants in Research Experience Survey Communicate sensitive information to patients Provide ongoing information to patients regarding their participation in research studies in writing, by telephone, and by e-mail Identify and report any adverse events and reactions in accordance with the study protocol Contribute to patient and public involvement and engagement activities Administrative Work with the multi-disciplinary team to conduct feasibility assessments for new research studies Assist the research team in administrative duties for study set-up, initiation, maintenance, study closure, and archiving Work with the Research and Innovation team to ensure compliance with regulatory requirements Set up and maintain study site files, electronic files and other documents as needed for studies Create digital patient tracking systems, e.g. using Excel Assist in the entry of accurate and timely documentation of data into participant Case Report Forms (CRFs) Assist with the resolution of raised data queries At all times ensure clear, accurate records are maintained by the research team Plan, organise, prepare and participate in monitoring visits and audits Update research management databases, including EDGE Ensure that patient identifiable records for research studies are stored according to Information Governance policies Assist with maintenance - ordering of research and office supplies Coordinate and disseminate amendments including preparation of any updated paperwork Liaise with trial units and commercial sponsors to coordinate trial activities Maintain financial information and patient records to allow payments to be made Handle petty cash and travel expense claims for patients Attend local and national meetings as required Record relevant meeting notes, minutes and actions, and circulate these appropriately General administrative duties including answering the telephone, answering queries, managing the research email inbox Maintain awareness of key performance indicators and next steps to achieve them Provide cover to other members of team as relevant to role Liaise with other departments for equipment maintenance, calibration and repair Training and Education As part of this role you will receive the following training: Trust Induction CREATE training (Clinical Research Explained) Improving Healthcare through Clinical Research MOOC Clinical skills training, including phlebotomy Good Clinical Practice training Data Quality in Research training Informed Consent training competency Site File Management training Case Report Form (CRF) completion training EDGE training Amendments training Archiving training iPROC system training Regular performance development reviews General Duties Travelling between sites is an essential part of this role Any other duties as may be agreed in the course of undertaking this role, in accordance with the grade and nature of the post