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DUTIES AND RESPONSIBILITIES:

• Day to day responsibility for the efficient and timely set up of clinical research. 
• Liaise with the wider clinical team to identify possible sources of patient recruitment.
• Manage own workload for daily research activity including case report form completion and amendment processing to meet internal and external deadlines. 
• Day to day responsibility for quality assurance of all research related documentation in accordance with relevant legislation and guidelines. 
• Lead on preparation for audit and inspections of research documentation as required.
• Advise and support CH&W Quality Manager on audit process/documentation.
• General trial-related communication in accordance with the Data Protection Act.

 
CLINICAL RESEARCH ADMINSTRATION AND DATA MANAGEMENT 

• Act as a point of contact between the R&D core team, study sponsors, clinical research organisations and specific research and clinical team, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to trial/project set up and general trial/project conduct. 
• Set-up and initiation of research within the team. 
• Maintain investigator site files in accordance with ICH-GCP and Trust SOPs. 
• Process study amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines. 
• Have administrative responsibility in liaison with the Clinical Research Nurse and Principal Investigators for safety reporting in accordance with protocol requirements. 
• Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas). 
• Produce study workbooks in collaboration with the Nurse Consultant and Principal Investigators. 
• Ensure collection of clinical case notes for all patients, so that these are available as needed, for monitoring and audit purposes. 
• Complete case report forms in collaboration with Research Nurses 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.
• Liaise with internal and external NHS staff regarding case notes, data collection and other general trial activities, which may be confidential and sensitive in nature. 
• Ensure that any additional source data is reproduced in a timely manner for the purposes of the clinical trial and dispatched according to study protocol. 
• Arrange team and trial/project related meetings as required, producing minutes in a timely manner. 
• Ensure that data is available and up to date for any meetings related to a clinical trial/project. 
• Attend project related meetings, investigator meetings (or teleconferences, as necessary) to convey the relevant information to the study team. 
• Facilitate preparation for audit and inspections as appropriate.
• Overseeing trial/project document archiving by following the Trust’s archiving guidelines.  

 
ADDITIONAL DUTIES

• Undertake qualitative research data collection / interviews, including awareness of when to pause interviews due to signs of participant distress. Debrief participants according to appropriate guidance and signpost them to relevant support if required.
• Collect data as required as part of a study including self-report measures and rating scales.
• Extract and code data from clinical notes.
• Analysis of qualitative data as appropriate in collaboration with relevant members of the research team.
• Facilitate recruitment, data monitoring, data collection, data entry and data analysis.
• Co-lead on reports, publications, and abstracts as appropriate.
• Ensure the security and confidentiality of data.
• Undertake relevant literature searches, summarising research, and drafting papers for publication.
• Prepare progress reports as necessary and undertake administrative tasks as needed.
• Ability to take informed consent from patient (parent/guardian, next of kin, as appropriate) ensuring full understanding of the nature of the research, voluntary participation, and freedom to withdraw at any time without prejudice to treatment and care.
• Provide verbal and written information and support to research participants for the duration of their involvement in the research project as appropriate.
• Support with completion of the study project plan/Gantt chart.
• Organise, attend, and write minutes for steering group and research team meetings as appropriate to individual studies.
• Share knowledge and information with colleagues regarding research studies in progress.
• Support/contribute to writing research grant applications.
• Support management in writing and updating relevant documents within the department.
   

WORKING PRACTICE

• Work closely with senior trial management / PI / Nurse Consultant as relevant to individual studies, to ensure adherence to SOPs and working procedures.
• Be pro-active in providing feedback on working practices within the research/clinical team and suggest new ways of working as appropriate. 
• Use initiative and be able to work independently without close supervision, plan and organise activity with prioritisation, referring to the Nurse Consultant as necessary. 
   

PERSONAL AND PEOPLE DEVELOPMENT 

• Maintain professional development (including GCP) whilst evaluating own specialist knowledge with assistance from the assigned line manager, to satisfy the NHS Knowledge and Skills Framework. 
• Participate in Trust-wide education programmes and study days, regional and national meetings, and research seminars as appropriate. 
• Assist with induction training and support for new post holders under the direction of the senior management team. 
• Ensure all mandatory training is up to date and further relevant training for the role is completed.
  
  

AD HOC DUTIES 

• Ensure that office supplies are adequate, ordered and obtained for the smooth running of the assigned research team. 
• Re-order trial related supplies as required.
• Assist in all areas of R&D administration as required. 
• Propose, conduct, and write up audit reports and service evaluations in collaboration with clinical team as appropriate.