Job Description

This is a 24-month contract inclusive of an 18-month apprenticeship.



Band 4 Annex 21 for the duration of the apprenticeship you will be paid 23,874. On successful completion of the apprenticeship the salary will be paid 27,485 for the remainder of the contract.



An exciting opportunity has arisen for an enthusiastic individual to embark on a Level 3 Business Administrator with AMSPAR Apprenticeship within the Research Division here at The Christie. The successful candidate will receive first class training and work towards formal qualifications whilst developing professional skills to provide support to the clinical research team with all aspects of clinical trials administration.



You will be based within the Breast research delivery team at The Christie, supporting a large number of commercial, NCRN and clinician-led trials.



Applicants should meet all the essential criteria described in the job description as a minimum. To be successful, you will need to show enthusiasm and motivation. We are looking for a candidates with good organisation and communication skills who can work well both in a team and using their own initiative.



As an Apprentice Clinical Trials Coordinator you will be trained to be a valuable member of our team, providing support such as assisting the research nurses, consultants and trial administration/ coordination management team with various aspects of clinical trial administration/ coordination work including; data management, case report form completion, invoicing, communication with trial sponsors, monitors and the wider research community, maintaining electronic records to support the team and assisting with the set up of new studies.

Please note:

the successful candidate will be required to undertake the Level 3 Business Administrator Apprenticeship qualification, along with the AMSPAR Level 2 Award in Medical Terminology qualification, as an integral part of this appointment.



The Christie NHS Foundation Trust is one of the leading cancer centres in Europe, offering high quality diagnosis, treatment and care as well as being at the forefront of cancer research and education.

As a key member of the Breast research delivery teams, you will be joining a busy, dynamic and supportive team.



The role is ideal for individuals keen to gain experience in clinical trials coordination.



Please read the eligibility criteria set out in the 'Apprenticeships - guidance for applicants' document attached to the NHS Jobs page for this vacancy. Please also be aware that there are a number of screening questions at the early stage of the on-line application process. These are designed to ensure that you are eligible for the apprenticeship. If you are not eligible the system will not allow you to proceed. Please read the apprenticeship guidance before responding to these questions and email any queries you may have to the-christie.apprenticeships@nhs.net before applying



The specific responsibilities will depend on the requirements of each team, but may include:



Act as a point of contact for the core Research and Development 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.



Set up and initiation of allocated trials within an assigned team, under the guidance of an experienced team member.



Track all payments throughout each clinical trial including completion of activity logs and requesting invoices to be raised.



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.



Provide administrative support to the Clinical Research Nurses 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 trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator for assigned studies and ensure version control is maintained.



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 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.



Arrange shipping and delivery of relevant trial data and documents including import/ export of tumour blocks, ECGs and copy scans.



Arrange team and trial 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.



If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team.



Assist with preparation for audit and inspections within assigned teams.



Assist with trial document archiving by following the Trust's archiving guidelines.



Ensure that office/ trial related supplies are adequate and assist with the ordering process.



Undertake general administrative tasks as delegated by managerial representatives from the Research Division to contribute to the smooth running of the patient recruitment teams.



Demonstrates the agreed set of values and accountable for own attitude and behaviour



WORKING PRACTICE



Work closely with the Research Division's 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 Research Portfolio Support Manager as necessary.



The post holder is guided by relevant protocols and SOPs, and expected to exercise judgement outside these areas. However, the Research Division's managerial team members are available as point of reference for any queries and will meet regularly with staff.



PERSONAL AND PEOPLE DEVELOPMENT



Maintain professional development 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.



Support with induction, for new post holders under the direction of the Research Division's management team.



PHYSICAL, MENTAL AND EMOTIONAL EFFORT



Long periods of time spent using keyboard to input information and use of VDU for electronic communication.



Prolonged concentration is regularly required (e.g. when checking through trial documentation and entering data into spreadsheets).



Occasional exposure to distressing circumstances as trial patients are commonly suffering from terminal illnesses.