Clinical Trials Coordinator

The-Christie-Nhs-Foundation-Trust; Manchester; On-site; GBP 23,000 - 29,000; Full time

Job summary

The Christie NHS Foundation Trust in Manchester is seeking a Clinical Trials Coordinator (Band 4) to join the Rare Tumour research team. You will support research nurses, consultants and trial coordination with data management, trial setup, invoicing and communications with sponsors.

You should have demonstrable knowledge of clinical trials/GCP and strong organisational and administration skills to ensure smooth trial operations and compliant documentation across multiple sites.

Qualifications

• Experience in administration including data management.
• Experience of working within a clinical trials environment.
• Knowledge of the clinical trials process and GCP guidelines/EU directives.

Responsibilities

• Act as a point of contact for the Research and Development team, sponsors, CROs and trial teams, communicating data queries and monitoring visits.
• Set up and initiation of allocated trials within an assigned team under guidance.
• Track payments and complete activity logs; raise invoices as needed.
• Maintain Investigator Site Files and essential docs to be inspection-ready.
• Process trial amendments in line with GCP and SOPs.
• Provide admin support for safety reporting and trial conduct requirements.

Skills

Organisational skills

Interpersonal skills

Communication skills

Education

Diploma / administration experience

Science or health-related degree

Clinical research training

Computing / IT qualification

Job description

We are looking to appoint a Clinical Trials Coordinator (Band 4) to the Rare Tumour research team within The Christie NHS Foundation Trust. The research teams form part of the Research and Innovation division.

We are seeking an enthusiastic, motivated and experienced individual who will be responsible for assisting the research nurses, consultants and trial coordination management team with various aspects of clinical trial administration/ coordination.

Applicants should have demonstratable working or academic knowledge of clinical trials/GCP and meet all the essential criteria on job description as a minimum. We are looking for a candidate with good organisational, communication skills and administration experience.

Main duties of the job

Applicants should meet all the essential criteria described in the job description as a minimum.

You will be responsible for 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.

You will be liaising with many different members of staff including internal service departments, central R&I office colleagues, 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.

Please see the attached job description for a more detailed description of the tasks this job will involve.

Working for our organisation

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.

Detailed job description and main responsibilities

• 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

Skills

• Good understanding and demonstrated use of Microsoft Word and Excel.
• Accuracy and attention to detail
• Good understanding and demonstrated use of the full Microsoft Office suite.

Other

• 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.
• Ability to troubleshoot effectively

Qualifications

• Diploma or administration experience.
• Degree in a science or health related discipline.
• Relevant training courses in clinical research.
• Qualification in computing or information technology /Relevant IT experience

Experience

• Experience in administration including data management.
• Experience of working within a clinical trials environment.
• Relevant experience within a Good Clinical Practice and research environment.

Knowledge

• Knowledge of the clinical trials process.
• Familiar with GCP guidelines/EU directives
• Understanding of medical terminology and cancer.
• Understanding of case report forms.
• Knowledge of clinical Governance.
• Knowledge of patient information systems.

Values

• Ability to demonstrate the organisational values and behaviours

Skills

• Good organisational skills.
• Good interpersonal skills.
• Good oral communication skills
• Good understanding and demonstrated use of the full Microsoft Office suite.

Other

• Tactful and Diplomatic
• Ability to troubleshoot effectively

The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.

Sponsorship Information - We are an approved sponsoring organisation. Applications will be considered from applicants requiring sponsorship alongside all other applications. Please be aware, not all roles are eligible for sponsorship. You can review the list of eligible role and requirements on the government website.

Pre-Employment Checks - To confirm your suitability for the role, we will carry out pre-employment checks in line with NHS Employment Check Standards . These include:

• Identity verification
• Right to work check
• Disclosure and barring service (DBS)/Criminal record check (dependent on role, payment of this will be the applicants responsibility)
• Professional registration and/or qualification check
• Occupational health assessment
• Employment history and reference validation

All applicants external to The Christie NHS Foundation Trust will be required to provide their HMRC employment history to cover the most recent three years employment. This information will used to validate employment history andreferences.

If you require sponsorship, we will assess your eligibility based on current government guidance. If the role is not eligible and you cannot demonstrate your right to work, your conditional offer may be withdrawn.

If You're Offered the Role - you will be agreeing to The Christie NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job information will also be transferred into the national NHS Electronic Staff Records system. Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.

The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and will form part of the recruitment process. In the event that you are successful following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.

No Smoking Policy - You should be aware the Trust operates a No Smoking Policy and therefore employees are not permitted to smoke at work.

Additional Information - We want to ensure that everyone who works at the Christie or uses our services is welcomed, valued and treated with dignity and respect.The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels. In support of these commitments, we particularly welcome applications from Black, Asian and other ethnic minority people and people with disabilities for this post. Appointment will be only on merit.

We are committed to creating a balanced and diverse workforce. As such we welcome and encourage applications from people of all backgrounds. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.

As users of the disability confident scheme, we guarantee to interview all disabled applicants who meet the minimum criteria for the vacancy.

The Christie NHS Foundation Trust is committed to the highest standards of ethical conduct and integrity in all our activities. We have a zero-tolerance approach to modern slavery in any of its forms, including slavery, servitude, forced or compulsory labour, and human trafficking. We are fully committed to acting ethically and with transparency in all our business dealings and relationships, and to implementing and enforcing effective systems and controls to ensure modern slavery is not taking place anywhere in our organisation or supply chains.

Employer certification / accreditation badges

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.