Apprentice Clinical Trials Coordinator

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

1. 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.
2. Set up and initiation of allocated trials within an assigned team, under the guidance of an experienced team member.
3. Track all payments throughout each clinical trial including completion of activity logs and requesting invoices to be raised.
4. 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.
5. Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
6. Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements.
7. Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas).
8. Produce trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator for assigned studies and ensure version control is maintained.
9. Ensure collection of clinical case notes for all patients, so that these are available as needed, for monitoring and audit purposes.
10. 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.
11. Cross check, confirm data and complete query resolution with sponsors and third parties in a timely manner.
12. Completion of clinical trial specific databases with data from various sources such as questionnaires, hospital records and other electronic and paper sources.
13. 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.
14. Arrange shipping and delivery of relevant trial data and documents including import/ export of tumour blocks, ECGs and copy scans.
15. Arrange team and trial related meetings as required, producing minutes in a timely manner.
16. Ensure that data is available and up to date for any meetings related to a clinical trial.
17. If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team.
18. Assist with preparation for audit and inspections within assigned teams.
19. Assist with trial document archiving by following the Trust's archiving guidelines.
20. Ensure that office/ trial related supplies are adequate and assist with the ordering process.
21. Undertake general administrative tasks as delegated by managerial representatives from the Research Division to contribute to the smooth running of the patient recruitment teams.
22. Demonstrates the agreed set of values and accountable for own attitude and behaviour.

1. Work closely with the Research Division's management team to ensure adherence to new SOPs and working procedures rolled out divisionally.
2. Be pro-active in providing feedback on working practices within the research team and suggest new ways of working.
3. 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.
4. 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.

1. Maintain professional development whilst evaluating own specialist knowledge with assistance from the assigned line manager, to satisfy the NHS Knowledge and Skills Framework.
2. Participate in Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate.
3. Support with induction, for new post holders under the direction of the Research Division's management team.

1. Long periods of time spent using keyboard to input information and use of VDU for electronic communication.
2. Prolonged concentration is regularly required (e.g. when checking through trial documentation and entering data into spreadsheets).
3. Occasional exposure to distressing circumstances as trial patients are commonly suffering from terminal illnesses.

1. GCSE Grades A* - C/ 9 - 4 in English and Maths or meet the Maths, English and ICT skills assessments at the level required for the apprenticeship on assessment at interview.
2. A willingness to complete the Level 3 Business Administrator Apprenticeship qualification and the AMSPAR Level 2 Award in Medical Terminology.

1. 5 GCSEs Grade A* - C/ 9 - 4 including: English, Mathematics and Information Technology or equivalent qualification.

1. Experience in prioritising and managing a busy workload.
2. Experience in effective written and verbal communication skills.

1. Experience of working within an administrative environment.

1. Excellent organisational and time management skills.
2. Excellent attention to detail.
3. Ability to work independently and as part of a team.

1. Good understanding and demonstrated use of the Microsoft Office suite.

1. Demonstrates willingness and enthusiasm for developing knowledge of clinical trials administration.

1. Awareness of clinical trials process.

1. Ability to demonstrate the organisational values and behaviours.

1. Ability to work to tight and/or unexpected deadlines.
2. Conscientious and hardworking.

The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.

We want to ensure that everyone who works at the Christie or uses our services is welcomed, valued and treated with dignity and respect. The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels. In support of these commitments, we particularly welcome applications from Black, Asian and other ethnic minority people and people with disabilities for this post. Appointment will be only on merit.

We are committed to creating a balanced and diverse workforce. As such we welcome and encourage applications from people of all backgrounds. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.

As users of the disability confident scheme, we guarantee to interview all disabled applicants who meet the minimum criteria for the vacancy.

All positions within the Christie are subject to the receipt of satisfactory written references, medical clearance and evidence of your Right to Work in the UK. Some roles will require a Disclosure & Barring Service (DBS) check. Please note if you are successfully appointed to a post with this Trust, you will be required to pay for your own DBS Disclosure.

By applying for this post you are agreeing to The Christie NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job information will also be transferred into the national NHS Electronic Staff Records system. Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.

If you have not heard from us within four weeks of the closing date, I regret that on this occasion your application will have been unsuccessful.

The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and will form part of the recruitment process. In the event that you are successful following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.

Overseas candidates wishing to apply for this position and who would require immigration sponsorship, may wish to self-assess the likelihood of obtaining a Certificate of Sponsorship for the post on the UKVI website.

You should be aware the Trust operates a No Smoking Policy and therefore employees are not permitted to smoke at work.

• Job Description and Person Specification (PDF, 208.6KB)
• The Christie Values and Behaviours (PDF, 919.5KB)
• Strategy Brochure (PDF, 1.0MB)
• Travel to The Christie (PDF, 3.8MB)
• Apprenticeships - Guidance for applicants (PDF, 200.5KB)