The main purpose of the role is to support the Experimental Cancer Medicine 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 the wider Clinical Research Team.
The post holder will assist with the administration of clinical trials from feasibility to archiving, including (but not limited to):
- Assist with the efficient and timely setup of clinical trials.
- Assist with tracking and raising invoices.
- Manage own workload for daily trial activities, including case report form completion and amendments, to meet deadlines.
- Assist with quality assurance of trial documentation in accordance with legislation and guidelines.
- Assist with audit and inspection preparations.
- Handle general trial-related communication in accordance with the Data Protection Act.
Main duties of the job
The specific responsibilities may include:
- Act as a point of contact for the R&I core team, study sponsors, CROs, and research teams regarding data queries, monitoring visits, and trial setup and conduct.
- Set up and initiate trials under the guidance of Senior Clinical Trials Coordinators.
- Track payments, complete activity logs, and request invoices.
- Maintain investigator files and documentation to ensure they are inspection-ready.
- Process trial amendments according to GCP, SOPs, and timelines.
- Support safety reporting for Clinical Research Nurses and Principal Investigators.
About us
The Christie is a leading cancer centre in Europe, treating over 60,000 patients annually. Based in Manchester, it serves a population of 3.2 million and is a national specialist. It offers radiotherapy, chemotherapy, complex surgery, and is a leader in cancer research with over 300 trials annually.
Job responsibilities
DUTIES AND RESPONSIBILITIES
The responsibilities may include:
- Act as a contact for the R&D team, sponsors, CROs, and research teams.
- Set up and initiate trials with guidance.
- Track payments and complete logs.
- Maintain trial documentation and ensure inspection readiness.
- Process amendments and support safety reporting.
- Complete team reports and produce trial workbooks.
- Ensure collection of clinical notes and complete case report forms.
- Coordinate data entry and resolve queries.
- Liaise with NHS staff regarding trial activities.
- Arrange data and document shipments.
- Organize meetings and prepare minutes.
- Assist with audits, archiving, and supplies.
- Perform general administrative tasks to support the team.
Person Specification
Qualifications
- Diploma or administrative experience.
- Degree in science or health-related field.
- Training in clinical research.
- IT qualifications or experience.
Experience
- Administrative and data management experience.
- Experience in clinical trials and GCP environment.
Skills
- Proficiency in MS Word and Excel.
- Attention to detail and organizational skills.
- Interpersonal and communication skills.
Knowledge
- Understanding of clinical trials and GCP guidelines.
- Knowledge of medical terminology, case report forms, and clinical governance.
Values and Other
- Ability to demonstrate organizational values.
- Flexible, hardworking, and able to work independently or in a team.
- Diplomatic, tactful, and problem-solver.
Disclosure and Barring Service Check
This post requires a DBS check due to the nature of the work involving confidential and sensitive information.
Salary: £26,530 to £29,114 per annum, pro-rata.