Clinical Trials Coordinator

The Christie NHS Foundation Trust; Manchester; On-site; GBP 22,000 - 26,000; Full time

Job summary

The Christie NHS Foundation Trust in Manchester is seeking a Clinical Trials Assistant (Band 3) to support clinical trial administration within the Renal and Oesophagogastric Research team. The role includes data entry from patient visits, responding to trial queries, filing, invoicing support, and liaising with the Research and Innovation team.

There is potential to progress to Clinical Trials Coordinator (Band 4) after a competency review.

Qualifications

• Diploma or administration experience.
• Degree in science or health related discipline.

Responsibilities

• Assist with entry of data from patient visits and trial records.
• Respond to trial queries and support trial coordination activities.
• Maintain investigator site files and essential documentation.
• Assist with invoicing and costing spreadsheets for trials.
• Liaise with Research and Innovation team and external contacts.
• Support preparation for audits and inspections.

Skills

Organisational skills

Communication skills

Multi-tasking

Attention to detail

Education

Diploma or administration experience

Degree in science or health related discipline

Tools

Microsoft Word

Microsoft Excel

Job description

This post is offered at 37.5 hours per week but we are happy to access flexible working or part time working requests.

We are looking to appoint a Clinical Trials Assistant (Band 3) in the Renal and Oesophagogastric Research team within The Christie NHS Foundation Trust. The role has scope to transition to that of a Clinical Trials Coordinator (Band 4) following successful completion of a competency review. The research teams form part of the Research and Innovation division and are made up of a multi-disciplinary group of staff who are dedicated to cancer research and treatment.

We are seeking an enthusiastic and motivated 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 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. Due to the vital nature of our work and the impact on patients and the research community, attention to detail is an essential skill.

For further specific information on this post, please contact:
Amna Khawaja (Research Portfolio Manager) [e-mail]

Main duties of the job

The administrative team members each 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, assisting with invoicing, working with members of the core Research and Innovation team, liaising with pharmaceutical contacts, and assisting colleagues with other administrative tasks.

We have a strong team working ethos and you will be required to work closely with different members of staff. The Clinical Trials Assistant / Coordinator role comes with full training, and the opportunity for additional training 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.

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

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 rials 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, 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 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 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.

Qualifications

• Diploma or administration experience
• Degree in a science or health related discipline

Experience

• Experience of administrative tasks including data management
• Previous experience of working within a clinical trials or research environment
• Experience of working within a health care system

Skills

• Good written and oral communication skills
• Accuracy and attention to detail
• Good understanding and demonstrated use of Microsoft Word and Excel
• Good organisational skills
• Good interpersonal skills
• Good understanding and demonstrated use of the full Microsoft Office suite

Knowledge

• Some understanding of the clinical trials process
• Understanding of medical terminology and cancer.
• Knowledge of patient information systems

Values

• Ability to demonstrate the organisational values and behaviours

Other

• 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 work to tight and/or unexpected deadlines

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.

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.