Clinical Trials Coordinator inManchester inManchester PUBLISHED 23 MAY 2024
The Christie NHS FT roI7Sm3e
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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 PrincipalInvestigators 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 Trusts 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.
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 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, motivated, and experienced 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.
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.
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 PrincipalInvestigators 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 Trusts 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.
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 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, motivated, and experienced 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.
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.
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