Job Description
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 identify strategies to find and assist in the enrolment of research participants. The post-holder will perform a range of clinical assessments in line with accepted standards of practice. They will communicate effectively 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 and maintenance of databases. They will be responsible for ordering study supplies. The post holder will ensure the well-being of participants by adhering to relevant regulations and local Standard Operating Procedures (SOPs) including Good Clinical Practice (GCP), Medicines for Human Use (Clinical Trials) Regulations, Research Governance Framework for Health and Social Care and the Human Tissue Act.
We are looking for a highly motivated and dynamic Assistant Clinical Research Practitioner who enjoys being at the forefront of research in a cancer care setting. The post holder will provide a full administrative service to the research team with responsibility for timely and accurate data reporting and will have a pivotal role in the clinical conduct of cancer clinical trials.
Applications are sought from recent University leavers, current research professionals and administrators with a life science background. We are looking for an enthusiastic individual with an eye for detail, excellent communication and organisational skills.
A large part of the role will focus on data entry so ability to extra data from medical records is key. As well as this being able to organise yourself, our patients and support departments is key part of the role.
Guy’s and St Thomas’ NHS Foundation Trust comprises five of the UK’s best known hospitals – Guy’s, St Thomas’, Evelina London Children’s Hospital, Royal Brompton and Harefield – as well as community services in Lambeth and Southwark, all with a long history of high quality care, clinical excellence, research and innovation.
We are among the UK’s busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark.
We have a long tradition of clinical and scientific achievement and – as part of King’s Health Partners – we are one of England’s eight academic health sciences centres, bringing together world-class clinical services, teaching and research. We have one of the National Institute for Health Research’s biomedical research centres, established with King’s College London in 2007, as well as dedicated clinical research facilities.
- 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 study protocol is adhered to at all times.
- Co-ordinate research clinics and co-ordinate a portfolio of studies in conjunction with team members. This involves planning and organising clinical study related care or tests in accordance with approved study protocols or departmental standard operating procedures.
- Establish 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 appointments and conduct telephone follow-up calls as required.
- Report any adverse events or health concerns which occur whilst the participant is taking part in the study, to an appropriate doctor or nurse in a timely manner and to the appropriate principal or co-investigator.
- Perform and record a range of clinical assessments in line with personal competencies and as stipulated in approved study protocols including 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.
- Responsible for ensuring safe and appropriate storage, shipment and documentation of specimens.
- Keep up to date with current practice for phlebotomy and venepuncture.
- Provide ongoing support to the participant and carer whilst participating in the clinical study.
- Communicate on a regular basis with senior medical staff, nursing, pharmacy, radiology, and pathology and laboratory staff.
- Liaise 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.
- Take responsibility for ensuring own knowledge of amendments and updates to studies you work on and assist the research team in ensuring that information relating to updates in the study protocols and guidelines are disseminated to key areas and personnel.
- 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 with external study coordinators and sponsor representatives, nationally and internationally.
- Send GP letters or other trial related material to relevant parties.
- Arrange, attend and record minutes for research and other relevant departmental meeting.
- Assist with the organisation and set up of selection and initiation and investigator meetings for studies.
- Attend national and international study specific meetings and disseminate information to members of the multi-disciplinary team as required.