Job Summary
Clinical Trials Assistant (Band 3) with scope to transition to a Clinical Trials Coordinator (Band 4) after successfully completing and passing a competency review. The post is offered at 37.5 hours per week with flexibility for part‑time or flexible working. The role is part of the Renal and Oesophagogastric Research team within The Christie NHS Foundation Trust, a multi‑disciplinary group dedicated to cancer research and treatment.
We are looking to appoint 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 and coordination.
Responsibilities
* Act as a point of contact for the Research and Development core team, study sponsors, clinical research organisations and specific research teams, communicating directly regarding data queries, monitoring visits and other enquiries relevant to general trial conduct.
* Assist with general administrative duties associated with the set up and initiation of trials 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, ensuring 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 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 (recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas).
* Assist Clinical Trials Coordinators with development of trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator.
* Ensure collection of clinical case notes for all patients for monitoring and audit.
* Complete case report forms as per sponsor requirements and liaise with clinical trial monitors to ensure data sent is valid and meets requirements.
* Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data and other general trial activities sensitive in nature.
* Arrange shipping and delivery of trial data and documents including import/export of tumour blocks, ECGs and copies.
* Arrange team and trial related meetings as required, producing minutes promptly.
* Ensure 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).
* Assist with preparation for audit and inspections within assigned teams under supervision of the Senior Clinical Trials Coordinators and lead Clinical Research Nurse.
* Assist with trial document archiving following the Trusts archiving guidelines.
* Ensure that office/trial related supplies are adequate and assist with ordering process.
* Undertake general administrative tasks delegated by managerial representatives to contribute to the smooth running of the patient recruitment teams.
* Demonstrate the agreed set of values and be accountable for own attitude and behaviour.
* Enter data from patient visits, respond to trial queries, complete trial‑related records, file key trial documents, and assist with invoicing.
Person Specification
Essential
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* Diploma or administration experience.
* Experience of administrative tasks including data management.
* 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.
* Some understanding of the clinical trials process.
* Familiar with GCP guidelines/EU directives.
* Ability to demonstrate the organisational values and behaviours.
* Flexible and able 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.
* Tactful and diplomatic.
Desirable
* Degree in a science or health related discipline.
* Relevant training courses in clinical research.
* Qualification in computing or information technology / relevant IT experience.
* Previous experience of working within a clinical trials or research environment.
* Experience of working within a health care system.
* Relevant experience within a Good Clinical Practice and research environment.
* Good understanding and demonstrated use of the full Microsoft Office suite.
* Ability to troubleshoot effectively.
* Understanding of medical terminology and cancer.
* Knowledge of patient information systems.
* Understanding of case report forms.
* Knowledge of clinical Governance.
Job Details
Band 3 – Salary £24,937 to £30,162 per annum, pro rata. Permanent contract, full‑time. Working pattern: 37.5 hours per week with flexibility for part‑time or flexible working. Location: Renal – Q01128, Wilmslow Road, Manchester, M20 4BX. Reference number: 413-102020‑RI‑SD.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and a Disclosure to the Disclosure and Barring Service (formerly known as CRB) is required to check for any previous criminal convictions.
Employer Details
The Christie NHS Foundation Trust Renal – Q01128, Wilmslow Road, Manchester, M20 4BX Website: https://www.christie.nhs.uk/
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