Clinical Trials Assistant Wolverhampton
Job description
The Clinical Trials Assistant role works closely with a clinical team on specific research trials, assisting in and helping to co-ordinate data collection for a caseload of patients participating in local, national and international trials.
The post holder will be required to be flexible and confident in working in multidisciplinary research teams to assist medical and allied healthcare professionals to provide greater choice to patients through participation in research trials.
We are looking for a highly motivated individual with a wider understanding of the operational requirements and interpersonal skills required to achieve quality and the high standards required by patients, relatives, trial monitors, medical staffs, research nurses, and the R&D Directorate Management.
Co-ordinate data collection for a caseload of patients participating in local, national and international trials
Be responsible for aspects of clinical trials administration
Sample collection and shipment, some studies may require the postholder to undertake phlebotomy
Data collection, entries and queries
Trial co-ordination
Aspects of patient care in compliance with Good Clinical Practice and other regulatory requirements
The Royal Wolverhampton NHS Trust is one of the largest NHS trusts in the West Midlands providing primary, acute and community services and we are incredibly proud of the diversity of both our staff and the communities we serve. We are building a workforce that can help us to fulfil our values, improve quality of care for patients, and solve the health care problems of tomorrow. We’re passionate about the value that diversity of thinking and lived experience brings in enabling us to become a learning organisation and leader in delivering compassionate care for our patients.
We are delighted that we have been rated as“Good”by CQC. We have achieved numerous awards; The Nursing Times Best Diversity and Inclusion Practice and Best UK Employer of the Year for Nursing Staff in 2020.
The Trust is a supportive working environment committed to creating flexible working arrangements that suit your needs and as such will consider all requests from applicants who wish to work flexibly.
The postholder will be responsible for clinical trials administration, data collection, data presentation, trial co-ordination and aspects of patient care in compliance with Good Clinical Research Practice and the European Directive.
- To disseminate information to consultants regarding new trials identified on the on the National Research portal to enable optimal patient recruitment.
- Assist in the preparation of documentation when submitting trial protocols and paperwork to various committees and regulatory agencies for review and approval (ethics and Research and Development etc).
- Assist in the set-up of trials on site i.e. liaise with trial centre and other relevant staff to organise trial set-up visit.
- Request patient notes for screening purposes.
- Identify patients suitable for entry into clinical trials by screening notes and attending Multi-Disciplinary Team meetings and clinics.
- Processing blood samples in accordance with specific study instructions/packaging of samples in line with biologic sample preparation guidelines.
- Consenting patients into non-clinical questionnaire only.
- Liaise with clinical teams to organise and ensure that trial specific investigations are undertaken as and when required.
- Liaise with Research nurse/radiographers/P.I’s to record, organise and ensure the timely administration of treatment and any necessary follow up investigations and visits.
- Assist in reviewing and recording treatments, adverse events, toxicities and response to treatment. Organise the collection, storage and shipment of protocol specific samples. Explain, dispense and collect patient quality of life questionnaires and diaries. Liaise with designated Pharmacist to co-ordinate the availability and dispensing of trial drugs if required on instruction from RGN/P.I/ Radiographer.
- In discussion with research nurse report adverse and serious adverse events to the relevant personnel and act as required.
- In conjunction with senior research nurses maintain contact with and provide on-going information and support to the patient in a sensitive and professional manner. Refer to other specialists as required in order to provide optimal patient care.
- Within a Clinical Trials Assistant capacity you would be expected to demonstrate an understanding of the implementation of Good Clinical Practice (GCP) whilst adhering to study protocols and SOP’s ensuring a safe environment for research participants. Liaise with trial centres and relevant departments in order to promote a good working environment and ensure the smooth running of clinical trials for patients.
- Work at all times according to regulations described in local Standard Operating Procedures, Good Clinical Research Practice and European Directive.
- Maintain adequate patient records and accurately document data collected in case report forms and nursing/medical notes.
- Forward trial data in a timely manner to the trial co-ordinating centre and liaise with their personnel as necessary.
- Ensure that clinical trial databases and logs are maintained.
- Ensure the confidentiality of verbal, written and computerised information.
- Will be required to complete necessary notes/research notes in preparation for patient visits.
- Where appropriate assist research nurse in facilitation of research clinics.
- Plan, prepare and participate in monitoring visits and respond to trial data queries.
- Provide information to allow for invoice to be raised for payments where appropriate.
- Attend local research meetings, induction and training programmes and any other relevant education and training days/programmes as appropriate.
- To assist in demonstrating the value of research and innovation activity as part of the R&D and CRN marketing initiatives.
- Provide support to other colleagues as required.
- To demonstrate a continuous process of professional and personal development in order to develop own and other skills.
- To comply with all Trust and Research and Development Directorate policies and procedures.
