Research Practitioner

7 months ago

Manchester, United Kingdom The Christie NHS FT Full time

DUTIES AND RESPONSIBILITIES CLINICAL Provide clinical care for research participants, as delegated by PIs and research nurses, within the boundaries of own knowledge, competence and skill level. Ensure that all research is undertaken according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies. Planning and organising day
- to-day research and other activities Conduct delegated data collection with participants, such as questionnaires and interviews. Collection of biological samples as required for the clinical protocol, this may include blood, urine, sputum, tissue including post-mortem samples.

Preparation of sampling kits as described in study laboratory manuals, maintaining laboratory stock and shipping & tracking of research samples. Undertake research-related activities as required such as clinical observations and NEWS2, blood glucose monitoring, blood sampling (venepuncture and other venous access), PK sampling, cannulation and ECGs. Assist with arranging the collection of biological samples as required and undertake sample processing, liaising and involving laboratory and biobanking staff where necessary. Undertake shipment of samples from the collection site to the analysis/storage site, ensuring the quality of the samples is maintained and in line with all local and national policy.

Attend individual project meetings as required. Contribute to clinical and research governance processes, including adverse event and incident reporting, supporting any investigations. Understand and deliver care in accordance with regulatory approved clinical research protocols. Ensure all clinical activities are recorded in appropriate systems in a timely manner.

Evening and weekend shifts may occasionally be required to meet the clinical needs of the service RESEARCH Act as a point of contact for the core Research and Innovation team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to trial set up and general trial conduct. Maintain investigator site files and essential documentation in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all times. Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines. Complete case report forms as per sponsor requirements, and liaise with clinical trial monitors to ensure the data sent is valid and their requirements are met at site monitoring visits.

Cross check, confirm data and complete query resolution with sponsors and third parties in a timely manner. Completion of clinical trial specific databases with data from various sources such as questionnaires, hospital records and other electronic and paper sources. Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data, and other general trial activities, which may be confidential and sensitive in nature. Ensure that data are available and up to date for any meetings related to a clinical trial.

If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team. Undertake general administrative tasks related to clinical trials as delegated by your line manager. Assist with preparation for audit and inspections within assigned teams. KEY VALUES Demonstrates the agreed set of values and accountable for own attitude and behaviour.

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