Clinical Research Practitioner
6 months ago
Are you an experienced and dynamic clinical research practitioner who can confidently lead our research teams and manage our growing portfolio of vaccine Research? Then this role might be for you
You will be joining an enthusiastic, friendly, and motivated multidisciplinary team in a dynamic teaching hospital in central London. You will be working across the multiple areas to deliver clinical research to a high standard. The research portfolio consists of COVID-19 research trials looking at treatments, prophylactic and other vaccines. You will work closely with the R&D Lead, Principal Investigators and clinical staff to ensure a safe and high-quality level of care for our patients and their families or carers.
The clinical research practitioner (CRP) will play a key role in ensuring that any research undertaken within the department safeguards the well-being of the patients and is conducted according to Good Clinical Practice (GCP), the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006. In conjunction with the other members of the team, facilitate the production of good quality of research.
The CRP will facilitate and aid in the recruitment of patients to clinical studies and trials which will require working flexibly across the disciplines for a successful outcome. They will also act as a patient advocate providing support and assistance as required and assist in the co-ordination and management of a portfolio of clinical research studies.
The Vaccine and Trials research team hosts a portfolio of clinical trials assessing the safety and efficacy of vaccines, treatments and prophylactics. The team is currently based within the St. Thomas’ hospital Clinical Research Facility and comprises of doctors, research nurses, clinical research practitioners, laboratory workers and administrators. You will complete a range of tasks across our varied portfolio of clinical trials. Individual responsibilities are allocated each week through a rota.
We will provide a comprehensive induction programme and ensure that all staff have tailored, individual personal development plans with support for further training. Opportunities for developing new research/clinical skills are available and actively encouraged. The role will require cross-site working which will entail working in COVID-19 and infectious positive areas and working in the community on occasion as the design of the trials we conduct evolve.
Clinical and Communication Responsibilities
Manage a caseload of participants acting as a professional in ensuring a duty of care to the participant and their families.
Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical trial protocol is adhered to at all times.
Devise, implement and evaluate strategies for identifying eligible participants for research studies, including by attending clinics, departments, screening notes/consultant referral and Multidisciplinary Team (MDT) meetings.
Participate in the informed consent process acting as a resource and support to participants and their families. For appropriate studies take informed consent and ensure on-going consent.
Co
- ordinate the research participant pathway from screening through to study closure.
Maintain adequate participant records and ensure all relevant information is documented in the medical electronic notes or relevant clinical information systems and communicated with clinical teams.
Report any adverse events or health concerns which occur whilst the participant is taking part in the study to the appropriate doctor or nurse in a timely manner, and to the appropriate principal or co-investigator.
Undertake a range of clinical tasks in line with personal competencies and as stipulated in approved study protocols such as blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, biological sample preparation within clinical area and laboratories as stipulated in approved protocols and laboratory manuals as required.
Responsible for safe tracking, storage, efficient transport and robust documentation of participants samples.
Liaise with the clinical team to organise and ensure that study specific investigations are undertaken according to the protocol, obtain and document the results.
Report any side effects or adverse events according to protocol guidelines and within the required timeframe.
Act as a patient advocate.
Report any deviation from normal practice to senior staff and agree changes in care programme.
Deal with concerns raised by participants and visitors in a proactive manner and take remedial action as necessary.
Report to the senior clinical research staff any clinical incidences. Assist in managing incidents, accidents and comp
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