An exciting opportunity has arisen for a Band 5 Clinical Research Practitioner to join our dynamic and friendly Paediatric Research team. The role will require the successful applicant to support on the delivery of the non- commercial study European Autism GEnomics Registry (EAGER). EAGER is a European multicentre study that aims to create a registry of 1500 autistic people and people who have rare genetic conditions associated with autism. The study is taking place within Evelina London Children's Hospital (ELCH) in conjunction with South London and Maudsley NHS Foundation Trust (SLAM) and will require the post-holder to work between ELCH, SLAM and Kings College London (KCL). This role is a grant funded position and will not be subject to renewal at the end of the fixed term contract date stated on the application.

Main duties of the job

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 the delivery and management of the study EAGER and perform a range of clinical assessments in line with accepted standards of practice. The post-holder will be required to travel across multiple sites (ELCH, KCL and SLAM) to recruit participants and deliver the study. 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 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).

About us

The candidate will be joining a dynamic, hardworking and supportive team of research nurses, clinical research practitioners and clinical investigators based within Wolf Clinical Research Facility, ELCH. The post-holder will work with a large multi-disciplinary team across ELCH, KCL and SLAM. The successful candidate will be working alongside leaders in the field of Paediatric Neurosciences.

Job description

Job responsibilities

• 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 EAGER study 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 as 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 possible 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.
• 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.

Person Specification

Knowledge/Qualifications

Essential

• Degree in life sciences or related field or equivalent theoretical knowledge
• Evidence of continuous professional development
• GCP training/certificate

Desirable

• Relevant course to clinical area

Experience

Essential

• Experience of working in a relevant research setting
• Experience of working on own and in multidisciplinary team
• Experience of working in a patient/participant facing role with clinical duties.
• Experience of working on interventional studies or complex/ large scale observational studies'

Desirable

• Experience with electronic case report forms and computer packages
• Experience supervising others
• Experience of working on clinical trials of drugs.

Skills

Essential

• Excellent interpersonal and influencing skills and ability to communicate well (written and verbally)
• Ability to work as an effective team member and using own initiative
• Up to date knowledge relevant to clinical research and good clinical practice
• Excellent organisational skills for self and others - Ability to co-ordinate clinics and participant visits in conjunction with multidisciplinary team

Desirable

• Presentation and teaching skills
• Ability to develop clinical skills required by the research protocols for example cannulation and serial sampling, processing biologic samples according to protocols and conducting ECG's.

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

Evelina London Children's Hospital

Westminster Bridge Road

London

SE1 7EH

Any attachments will be accessible after you click to apply.

196-RD027