Clinical Trials Coordinator

We are seeking an enthusiastic, motivated and experienced individual who will be responsible for various aspects of clinical trial coordination including liaising with trial sponsors, monitors and the wider research community, maintaining essential documentation, managing the set-up of new studies and overseeing the day to day running of open studies.

The successful candidate will need to demonstrate knowledge of the clinical trials process, and be IT literate with previous experience of administrative work. We are looking for a candidate with good organisation and communication skills; who can work well both in a team and using their own initiative.

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 specific responsibilities will depend on the requirements of each team, but may include:

Act as a point of contact for the R&I 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 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.

Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.

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

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% 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.

DUTIES AND RESPONSIBILITIES

The specific responsibilities will depend on the requirements of each team, but may include:

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…