Clinical Trials Coordinator

The Christie NHS FT; Manchester; On-site; GBP 27,000 - 31,000; Full time

Job summary

A leading cancer research center in Manchester is seeking a clinical trials administrator to support the clinical research team. Responsibilities include assisting with clinical trials from setup to archiving, ensuring compliance with Good Clinical Practice (GCP), and managing documentation. Candidates should have a relevant degree and experience in clinical trials administration. The role offers a salary range of £27,485 to £30,162 per year, pro rata.

Qualifications

• Relevant research experience required.
• Experience in clinical trial administration including data management.
• Experience of working within a clinical trials environment.

Responsibilities

• Support the clinical research team with trial administration.
• Assist with clinical trials from feasibility to archiving.
• Manage workload for daily trial activity including documentation.

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

Education

Degree in a science or health related discipline

Diploma or administration experience

Relevant training courses in clinical research

Qualification in computing or information technology

Job description

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.

The post holder will assist with the administration of clinical trials from feasibility to archiving including:

• Assist with the efficient and timely set up of clinical trials.
• Assist with the tracking and raising of invoices.
• Manage own workload for daily trial activity including case report form completion and amendment processing to meet internal and external deadlines.
• Assist with quality assurance of all trial related documentation in accordance with relevant legislation and guidelines.
• Assist with preparation for audit and inspections within assigned teams.
• General trial-related communication in accordance with the Data Protection Act.

PLEASE REFER TO THE JOB DESCRIPTION FOR A FULL LIST OF DUTIES.

Job 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 is accountable for own attitude and behaviour.

About us

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 % of 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.

Person Specification

Qualifications

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

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.

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.

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.
• Tactful and diplomatic.
• 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.

£27,485 to £30,162 a yearper annum pro rata