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 12 months - £20,380pa. Final 6 months - 20,697pa. On successful completion of the apprenticeship the salary will be £25,147.
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.
Main duties of the job
You will be based within the Haematology & Transplant 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 candidate 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 is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
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 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 Trusts archiving guidelines.
- Ensure that office/ trial related supplies are adequate and assist with the ordering process.
- Undertake general administrative tasks as delegated by managerialrepresentatives 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 behaviou
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 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 Divisions 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 Divisions 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 distressed circumstances as trial patients are commonly suffering from terminal illnesses.
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 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 Trusts archiving guidelines.
- Ensure that office/ trial related supplies are adequate and assist with the ordering process.
- Undertake general administrative tasks as delegated by managerialrepresentatives 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 behaviou
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 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 Divisions 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 Divisions 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 distressed circumstances as trial patients are commonly suffering from terminal illnesses.
Person Specification
Qualifications
Essential
- 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.
- A willingness to complete the Level 3 Business Administrator Apprenticeship qualification and the AMSPAR Level 2 Award in Medical Terminology
Desirable
- 5 GCSEs Grade A* - C/ 9 - 4 including: English, Mathematics and Information Technology or equivalent qualification
Experience
Essential
- Experience in prioritising and managing a busy workload
- Experience in effective written and verbal communication skills
Desirable
- Experience of working within an administrative environment
Skills
Essential
- Excellent Organisational and time management Skills
- Excellent attention to detail
- Ability to work independently and as part of a team
Desirable
- Good understanding and demonstrated use of the Microsoft Office suite.
Knowledge
Essential
- Demonstrates willingness and enthusiasm for developing knowledge of Clinical Trials Administration
Desirable
- Awareness of Clinical Trials Process
Values
Essential
- Ability to demonstrate the organisational values and behaviours
Other
Essential
- Ability to work to tight and/or unexpected deadlines
- Conscientious and hardworking
Person Specification
Qualifications
Essential
- 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.
- A willingness to complete the Level 3 Business Administrator Apprenticeship qualification and the AMSPAR Level 2 Award in Medical Terminology
Desirable
- 5 GCSEs Grade A* - C/ 9 - 4 including: English, Mathematics and Information Technology or equivalent qualification
Experience
Essential
- Experience in prioritising and managing a busy workload
- Experience in effective written and verbal communication skills
Desirable
- Experience of working within an administrative environment
Skills
Essential
- Excellent Organisational and time management Skills
- Excellent attention to detail
- Ability to work independently and as part of a team
Desirable
- Good understanding and demonstrated use of the Microsoft Office suite.
Knowledge
Essential
- Demonstrates willingness and enthusiasm for developing knowledge of Clinical Trials Administration
Desirable
- Awareness of Clinical Trials Process
Values
Essential
- Ability to demonstrate the organisational values and behaviours
Other
Essential
- Ability to work to tight and/or unexpected deadlines
- Conscientious and hardworking
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.
