Job summary
This is a 24-month contract inclusive of an 18-month apprenticeship.
Band 4 Annex 21 for the duration of the apprenticeship: First 6 months - £20,380pa; Next 12 months - £20,697pa. On successful completion of the apprenticeship the salary will be £25,147pa for the remainder of the contract.
An exciting opportunity has arisen for two enthusiastic individuals to embark on a Level 3 Business Administrator with AMSPAR Apprenticeship within the Research Division here at The Christie. The successful candidates 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.
Apprenticeship eligibility criteria:
GCSE A*-C/9-4 or Level 2 Functional Skills in English and Maths is required for successful completion of the course.
If you have previously studied a Business-related course at Level 3 or above, you will not be eligible. If you have already started your Business Administration apprenticeship with another employer then please contact the Apprenticeships Team to discuss eligibility.
If you currently hold a temporary VISA, work or residency permit, please get in touch with the Apprenticeships Team prior to applying to discuss eligibility in line with national funding criteria.
Main duties of the job
You will be based within the Melanoma or Late Phase Research Team at The Christie, supporting many 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 candidate(s) 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.
About us
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 Melanoma or Late Phase Research Team, 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 several 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.
Job description
Job responsibilities
DUTIES AND RESPONSIBILITIES
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 visitsand 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 the Senior Clinical Trials Coordinators.
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 alltimes.
Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
Provide administrative support to the Clinical Research Nurses and PrincipalInvestigators 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 includingimport/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 Trusts 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.
Job description
Job responsibilities
DUTIES AND RESPONSIBILITIES
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 visitsand 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 the Senior Clinical Trials Coordinators.
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 alltimes.
Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
Provide administrative support to the Clinical Research Nurses and PrincipalInvestigators 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 includingimport/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 Trusts 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.
Person Specification
Qualifications
Essential
- Diploma or administration experience
Desirable
- Degree in a science or health related discipline
- Relevant training courses in clinical research
- Qualification in computing or information technology/Relevant IT experience
Experience
Essential
- Experience in administration including data management
Desirable
- Experience of working within a clinical trials environment
- Relevant experience within a Good Clinical Practice and research environment
Skills
Essential
- Good written communication skills
- Good understanding and demonstrated use of Microsoft Word and Excel
- Accuracy and attention to detail
- Good organisational skills.
- Good interpersonal skills
- Good oral communication skills
Desirable
- Good understanding and demonstrated use of the full Microsoft Office suite.
Knowledge
Essential
- Knowledge of the clinical trials process
- Familiar with GCP guidelines/EU directives
Desirable
- Understanding of medical terminology and cancer
- Understanding of case report forms
- Knowledge of clinical Governance
- Knowledge of patient information systems
VALUES
Essential
- Ability to demonstrate the organisational values and behaviours
OTHER
Essential
- Ability to work to tight and/or unexpected deadlines
- Flexible with ability to adapt to service requirements
- Hardworking; ability to manage a busy workload
- Ability to work unsupervised or as part of a team
- Tactful and diplomatic.
Desirable
- Ability to troubleshoot effectively
Person Specification
Qualifications
Essential
- Diploma or administration experience
Desirable
- Degree in a science or health related discipline
- Relevant training courses in clinical research
- Qualification in computing or information technology/Relevant IT experience
Experience
Essential
- Experience in administration including data management
Desirable
- Experience of working within a clinical trials environment
- Relevant experience within a Good Clinical Practice and research environment
Skills
Essential
- Good written communication skills
- Good understanding and demonstrated use of Microsoft Word and Excel
- Accuracy and attention to detail
- Good organisational skills.
- Good interpersonal skills
- Good oral communication skills
Desirable
- Good understanding and demonstrated use of the full Microsoft Office suite.
Knowledge
Essential
- Knowledge of the clinical trials process
- Familiar with GCP guidelines/EU directives
Desirable
- Understanding of medical terminology and cancer
- Understanding of case report forms
- Knowledge of clinical Governance
- Knowledge of patient information systems
VALUES
Essential
- Ability to demonstrate the organisational values and behaviours
OTHER
Essential
- Ability to work to tight and/or unexpected deadlines
- Flexible with ability to adapt to service requirements
- Hardworking; ability to manage a busy workload
- Ability to work unsupervised or as part of a team
- Tactful and diplomatic.
Desirable
- Ability to troubleshoot effectively
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
