The post holder will be expected to coordinate 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.., 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
Kettering General Hospital NHS Foundation Trust is one of the largest employers in the area and we are on an exciting journey. Our mission is to provide safe, compassionate, and clinically excellent patient care, by being an outstanding employer for our people. We have entered into a Group Model with neighbouring Northampton General Hospital and have become University Hospitals of Northamptonshire. Our Excellence Values: Compassion Respect Integrity Courageous Accountable