About this role
Job summary
An exciting opportunity has arisen within the Research and Innovation Division at The Christie to join our Surgical and Anaesthetics Research Team, supporting the delivery and continued growth of a diverse clinical research portfolio.We are seeking an enthusiastic, motivated and experienced individual to provide high-quality clinical trial administration and coordination, working closely with research nurses, surgeons, consultants and the wider trial coordination team.As part of a small team, you will need to work confidently and independently, effectively manage competing priorities and contribute to divisional, Trust and national research objectives.
You will need excellent organisational and communication skills, attention to detail and the ability to manage competing priorities in a busy research environment. You should be proactive, adaptable and enjoy working collaboratively as part of a multidisciplinary team. This is an excellent opportunity for someone with strong administrative skills who is interested in developing their career within clinical research and contributing to high-quality cancer research at The Christie.
Main duties of the job
Practice (GCP), Trust procedures and study protocols. Key responsibilities will include:o Supporting the set-up, amendment and ongoing administration of clinical trials.o Completing case report forms and maintaining accurate trial databases, trackers and electronic records.o Maintaining essential trial documentation and investigator site files to ensure they remain inspection ready.o Responding to data queries and liaising with sponsors, monitors, research organisations and internal teams.o Tracking trial activity and supporting invoicing and financial processes.o Supporting monitoring visits, audits and inspections.o Working closely with Research Nurses and Principal Investigators to support effective study delivery.o Managing your own workload, prioritising competing demands and meeting internal and external deadlines. You will work both independently and collaboratively, using initiative while ensuring high standards of accuracy, confidentiality and research governance.
About us
The Christie is one of Europe's leading cancer centres, looking after more than 64,000 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 25% patients are referred to us from other parts of the country.
We are the largest radiotherapy provider in the NHS with one in 20 treatments delivered at The Christie. We have up to 15 linear accelerators operating across our network of sites. We operate the largest chemotherapy unit in the UK on our main site and treatments are also provided at 13 other networked sites, and in patients homes. And as a specialist tertiary surgical centre, we focus on rare cancers, complex procedures, and multidisciplinary approaches to cancer surgery, specialising in colorectal, peritoneal, gynaecological, urological and plastic surgery.
We are also an international leader in research, with world first breakthroughs for over 100 years. We have been named by the UK's National Institute for Health Research (NIHR), as one of the best hospitals providing opportunities for patients to participate in clinical research studies, with more than 800 studies open at any time, caring for over 3,000 patients.
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 Trial 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.
Employer details
Employer name
The Christie NHS FT
Address
Surgical and Anaesthetic Research - Q02842
Manchester
M20 4BX
United Kingdom
Employer's website
https://www.christie.nhs.uk/ (Opens in a new tab)