Job summary
- Main area
- Research & Innovation
- Grade
- Band 4
- Contract
- Permanent
- Hours
- Full time - 37.5 hours per week
- Job ref
- 413-102731-RI-MS
- Employer
- The Christie NHS Foundation Trust
- Employer type
- NHS
- Site
- Clinical Trials Department - Q02054
- Town
- Manchester
- Salary
- £27,485 - £30,162 per annum pro rata
- Salary period
- Yearly
- Closing
- 11/02/2026 23:59
Employer heading
Clinical Trials Coordinator
Band 4
Job overview
We are seeking an enthusiastic, motivated and experienced individual who will be responsible for various aspects of clinical trial coordination including liaising with trial sponsors, monitors and the wider research community, maintaining essential documentation, managing the set-up of new studies and overseeing the day to day running of open studies.
The successful candidate will need to demonstrate knowledge of the clinical trials process, and be IT literate with previous experience of administrative work. 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.
The main purpose of the role is to support the clinical research team with all aspects of clinical trials administration, according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies. The post holder will provide support to the Senior Clinical Trials Coordinators and wider Clinical Research Team.
Main duties of the job
The specific responsibilities will depend on the requirements of each team, but may include:
· Act as a point of contact for the R&I 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 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.
· Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
PLEASE REFER TO THE JOB DESCRIPTION FOR A FULL LIST OF DUTIES.
Working for our organisation
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.
Detailed job description and main 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 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 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.
Person specification
Qualifications
Essential criteria
- Diploma or administration experience.
Desirable criteria
- 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 criteria
- Experience in administration including data management.
Desirable criteria
- Experience of working within a clinical trials environment.
- Relevant experience within a Good Clinical Practice and research environment.
Skills
Essential criteria
- 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 criteria
- Good understanding and demonstrated use of the full Microsoft Office suite.
Knowledge
Essential criteria
- Knowledge of the clinical trials process.
- Familiar with GCP guidelines/EU directives
Desirable criteria
- Understanding of medical terminology and cancer.
- Understanding of case report forms.
- Knowledge of clinical Governance
- Knowledge of patient information systems.
Values
Essential criteria
- Ability to demonstrate the organisational values and behaviours
Other
Essential criteria
- 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 criteria
- Ability to troubleshoot effectively
Documents to download
Further details / informal visits contact
- Name
- Greta Narkute
- Job title
- Research Portfolio Manager
- Email address
- [email protected]
- Telephone number
- 0161 918 2375
- Additional information
Greta Narkute, telephone 0161 918 2375, email [email protected]
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