clinical research associate Manchester, England
Job description
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 etc.
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 appropriately escalating unwell patients to senior nursing and medical staff. Blood glucose monitoring, blood sampling (venepuncture and other venous access), PK sampling, cannulation and ECGs. 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 Lead and co-ordinate Clinics.
Ensure documentation is prepared and ready for use by clinicians. Ensure tasks delegated appropriately. 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 is 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. Facilitating team projects, internal studies and audits. WORKING PRACTICE Work closely with the Research Divisions management team to ensure adherence to new SOPs and working procedures rolled out divisionally. Be pro-active in providing feedback on working practices within the research team and suggest new ways of working.
The post holder is expected to use initiative and be able to work independently without close supervision. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to the Senior Clinical Trials Coordinators/ Research Nurses as necessary. Personal Education, Training and Development Undertake continuous professional development, seeking opportunities to enhance skills via a personal development plan. Participation in trust-wide education programmes and study days.
To keep up to date with departmental, Trust, UK and EU developments for the management of clinical research ensuring timely, effective implementation of changes.
