Clinical Research Practitioner London, England
Job description
An exciting opportunity has arisen for a Band 5 Children’s Clinical Trials Practitioner, to join our dynamic and friendly Paediatric Genetics Research team. The role would be to support the B6 Research nurses and lead on the delivery of high quality, holistic care to children and young people participating in the paediatric genetic research portfolio. Working within Specialist Ambulatory Service and Evelina Paediatric Research, we aim to deliver safe clinical trials to children with rare diseases.
Acting as patient and participant advocate at all times, the post holder will be expected to co-ordinate research clinics and organise study related care. They will implement and evaluate strategies to identify and assist in the enrolment of research participants. The post-holder will lead on a portfolio of research studies and perform a range of clinical assessments in line with accepted standards of practice. They will communicate proactively with the study and clinical teams to ensure good participant experience and adherence to study protocols. The post holder will be responsible for case report form completion, site file management, implementation of amendments and maintenance of databases. They will act as mentor and support for new and junior team members. They will contribute to quality assurance processes within the team. The post holder will ensure the well-being of participants by adhering to study protocols, relevant regulations and local Standard Operating Procedures (SOPs).
The candidate will be joining a dynamic, hardworking and supportive team of coordinators and clinical investigators, covering novel and exciting clinical research trials. You will be working alongside leaders in the field of Paediatric Genetics Research.
- Provide excellent customer care skills to ensure patients and participants come first.
- 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.
- Lead on a portfolio of trials and coordinate participation. This requires liaising with the clinical team to organise and ensure that trial specific investigations are undertaken according to the protocol, paying particular attention to accurate data collection and dissemination and version control of essential documentation.
- Devise, implement and evaluate strategies for recruiting participants into clinical studies and identify individuals potentially eligible for research studies. Gain permissions for research contacts.
- For specific studies post holder may be delegated to obtain consent from participants in line with Trust policy and research protocol.
- Organise and facilitate participant appointments and follow-up phone calls.
- Accurately perform and record observations of clinical activities required according to personal competencies and the study protocol and obtain the results including blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
- 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.
- Liaise with pharmacy to co-ordinate the availability and dispensing of study drugs if appropriate.
- Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, tissue and blood sample preparation within clinic and laboratory in line with personal competencies and approved study protocol
- Process biological samples according to personal competencies and the study-specific protocol and laboratory manual and organise the storage, shipment and documentation of samples.
- Provide ongoing support to the participant and carer whilst participating in the clinical study.
- Communicate study related information effectively with the research team and study participants and their family members. This information may be complex or sensitive, and there may be barriers to understanding.
- Communicate effectively and efficiently specialised advice pertaining to research protocols to members of the multidisciplinary team.
- Engage effectively with other departments and wards at the site/s, in order to promote a good working environment, integration of research and open channels of communication.
- Communicate with external study coordinators and sponsor representatives, nationally and internationally.
- Attend and participate in departmental meetings and help promote new ideas and methods and assist in their implementation.
- Attend and participate in multidisciplinary team meetings.
- Arrange, attend and record minutes for research and other relevant departmental meeting.
- Attend national and international study specific meetings and disseminate information to members of the multi-disciplinary team as required.
