Job summary
Please note that this post is offered as a fixed term contract for 12 months at 37.5 h/week.
We are looking to appoint a university placement student for 12 months in a Clinical Trials Assistant position to join a research delivery team within The Christie NHS Foundation Trust.
We are seeking an enthusiastic and highly motivated individual, who is wanting to expand their knowledge and interest in clinical trials administration, coordination, and data management. The role will enable you to get an understanding of clinical research, ICHGCP and clinical trial governance. We are looking for an individual with passion for applying organisational skills to day-to-day clinical trial coordination, whilst using their interpersonal skills to communicate effectively with a range of collaborators.
The successful applicant will become part of the Lymphoma, Haematology, Renal/OG, Breast, Lung or Early Phase Oncology Research Teams.
This is primarily an office-based role with the occasional opportunity for shadowing patient clinics, or other teams or departments. Post holders will not be required to undertake practical lab work.
Main duties of the job
Applicants should meet all the essential criteria described in the job description as a minimum.
The post holder will assist with the provision of a high quality and efficient administrative service. You will work with Clinical Trial Coordinators and Data Managers on a wide aspects of clinical trials administration.
You will be assigned your own workload / portfolio of studies and help the team with the daily trials' activity. These may include assisting with general administration associated with set up of clinical trials, regular trial management, completing activity logs to enable invoices being raised, entering data into data capture systems (electronic and paper) and maintaining electronic records to support the team.
You will be liaising with many different members of staff including internal service departments, central R&I office colleagues, specialist clinicians and research nurses, as well as external collaborators, i.e. trial sponsors, monitors and the wider research community, so good communication and interpersonal skills are key
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 Research and Development core team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to general trial conduct.
- Assist with the general administrative duties associated with the set up and initiation of trials within an assigned team, under the supervision of the Senior Clinical Trials Coordinators.
- Assist with completion of activity logs to enable 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.
- Assist with the processing of trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines, under the supervision of the Senior Clinical Trials Coordinators.
- Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements, under the supervision of the Senior Clinical Trials Coordinators.
- Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas).
- Assist the Clinical Trials Coordinators with the development of trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator.
- 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. This will be under the supervision of the Senior Clinical Trials Coordinators
- Liaise with internal and external NHS staff regarding case notes, datacollection, 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 in collaboration with the Senior Clinical Trials Coordinators.
- Attend project related meetings, investigator meetings (abroad or teleconferences, as necessary).
- Assist with general preparation for audit and inspections within assigned teams, under the direct supervision of the Senior Clinical Trials Coordinators and lead Clinical Research Nurse.
- 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 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 Research and Development core team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to general trial conduct.
- Assist with the general administrative duties associated with the set up and initiation of trials within an assigned team, under the supervision of the Senior Clinical Trials Coordinators.
- Assist with completion of activity logs to enable 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.
- Assist with the processing of trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines, under the supervision of the Senior Clinical Trials Coordinators.
- Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements, under the supervision of the Senior Clinical Trials Coordinators.
- Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas).
- Assist the Clinical Trials Coordinators with the development of trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator.
- 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. This will be under the supervision of the Senior Clinical Trials Coordinators
- Liaise with internal and external NHS staff regarding case notes, datacollection, 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 in collaboration with the Senior Clinical Trials Coordinators.
- Attend project related meetings, investigator meetings (abroad or teleconferences, as necessary).
- Assist with general preparation for audit and inspections within assigned teams, under the direct supervision of the Senior Clinical Trials Coordinators and lead Clinical Research Nurse.
- 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 behaviour.
Person Specification
Qualifications
Essential
- Diploma or administration experience
Desirable
- Degree in a science or health related discipline.
- Relevant research experience
Experience
Essential
- Experience of administrative tasks including data management.
Desirable
- Previous experience of working within a clinical trials environment.
- Experience of working within a health care system.
Skills
Essential
- Good written communication skills.
- Accuracy and attention to detail. Good understanding and demonstrated use of Microsoft Word and Excel.
- Good organisational skills.
- Good interpersonal skills.
- Good oral communication skills.
Desirable
- Good understanding and demonstrated use of the full Microsoft Office suite.
Knowledge
Essential
- Some understanding of the clinical trials process
Desirable
- Understanding of medical terminology and cancer. Knowledge of patient information systems.
Values
Essential
- Ability to demonstrate the organisational values and behaviours
Other
Essential
- 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
Desirable
- Ability to work to tight and/or unexpected deadlines.
Person Specification
Qualifications
Essential
- Diploma or administration experience
Desirable
- Degree in a science or health related discipline.
- Relevant research experience
Experience
Essential
- Experience of administrative tasks including data management.
Desirable
- Previous experience of working within a clinical trials environment.
- Experience of working within a health care system.
Skills
Essential
- Good written communication skills.
- Accuracy and attention to detail. Good understanding and demonstrated use of Microsoft Word and Excel.
- Good organisational skills.
- Good interpersonal skills.
- Good oral communication skills.
Desirable
- Good understanding and demonstrated use of the full Microsoft Office suite.
Knowledge
Essential
- Some understanding of the clinical trials process
Desirable
- Understanding of medical terminology and cancer. Knowledge of patient information systems.
Values
Essential
- Ability to demonstrate the organisational values and behaviours
Other
Essential
- 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
Desirable
- Ability to work to tight and/or unexpected deadlines.
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.
