Job summary
Please note that this post is for 37.5 hours per week.
We are looking to appoint a Clinical Trials Coordinator (NHS Agenda for Change Band 4) in the Renal and Oesophagogastric Research team within The Christie NHS Foundation Trust. The research team is part of the Research and Innovation division and is made up of a multi-disciplinary group of staff who are dedicated to cancer research and treatment.
We are seeking an enthusiastic, motivated, and experienced individual who will be responsible for managing a portfolio of clinical trials with support from research nurses, consultants, and the trial administration team.
Applicants should meet all the essential criteria on the job description as a minimum. We are looking for a candidate with good organisational and communication skills, with the ability to multi-task. Experience in clinical trials coordination is essential, and knowledge of renal or oesophagogastric clinical trials is preferred. Due to the vital nature of our work and the impact on patients and the research community, attention to detail is an essential skill.
Main duties of the job
The post holder will manage a portfolio of clinical trials with support from other colleagues. The day-to-day role includes entering data from patient visits, responding to trial queries, completing trial-related records, filing key trial documents, invoicing, working with members of the core Research and Innovation team, liaising with pharmaceutical contacts, and processing trial amendments.
We have a strong team working ethos and you will be required to work closely with different members of staff. The role comes with full training, and the opportunity for additional conferences and sessions to support career development within the Trust.
The Renal and Oesophagogastric team works on studies including early phase, biomarker trials, real-world data, radiotherapy and will eventually be involved in innovative proton beam trials. The Christie's research teams contribute towards pioneering research and innovation, and we constantly work towards improving cancer care and patient outcomes. A role within our team is challenging but rewarding; we are a hard-working and friendly team with a passion for research and patient care.
About us
The Christie NHS Foundation Trust is one of the largest cancer treatment centres in Europe, and an international leader in cancer research and development. We are one of the leading centres in the UK for clinical trials and radiotherapy research. Treating more than 40,000 patients a year, we are the first UK centre to be officially accredited as a comprehensive cancer centre. The Clinical Research Facility (CRF) at The Christie is also one of four specialist units in Manchester for experimental research that make up the NIHR Manchester CRF, providing us with the dedicated space and expertise required to deliver intensive and complex studies in safe environment. The Christie is home to one of only two high energy NHS proton beam therapy (PBT) centres in the UK where we provide specialised treatment for UK patients with complex and hard-to-treat cancers.
Job description
Job 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 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
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 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.
