Job summary
Please note that this post is offered as a permanent contract at 37.5 h/week.
We are looking to appoint a Clinical Trials Assistant (Band 3) with scope to transition to a Clinical Trials Coordinator (Band 4) after a competency review to join the Lymphoma research delivery team within The Christie NHS Foundation Trust.
We are seeking an enthusiastic and highly motivated individual, who is wanting to expand their knowledge and interest in clinical trials administration, coordination, and data management. The role will enable you to get an understanding of clinical research, ICHGCP and clinical trial governance. We are looking for an individual with passion for applying organisational skills to day-to-day clinical trial coordination, whilst using their interpersonal skills to communicate effectively with a range of collaborators.
Applicants should meet all the essential criteria described in the job description as a minimum.
Main duties of the job
The post holder will assist with the provision of a high quality and efficient administrative service. You will work with Clinical Trial Coordinators and Data Managers on a wide aspects of clinical trials administration.
You will be assigned your own workload / portfolio of studies and help the team with the daily trials' activity. These may include assisting with general administration associated with set up of clinical trials, regular trial management, completing activity logs to enable invoices being raised, entering data into data capture systems (electronic and paper) and maintaining electronic records to support the team.
You will be liaising with many different members of staff including internal service departments, central R&I office colleagues, lymphoma clinicians and research nurses, as well as external collaborators, i.e. trial sponsors, monitors and the wider research community, so good communication and interpersonal skills are key.Lymphoma covers a wide range of different disease types and the research landscape is constantly evolving. The portfolio consists of a range of studies including new systemic treatments, radiotherapy, CAR-T and bio-banking/observational providing a varied role for team members.
About us
The Christie NHS Foundation Trust is one of the leading cancer centres in Europe, offering high quality diagnosis, treatment and care as well as being at the forefront of cancer research and education.
As a key member of a disease research team, you will be joining a busy, dynamic and supportive group who are passionate about clinical trials. Lymphoma, Haematology and Breast cover a wide range of different disease types and the research landscape is constantly evolving. The portfolio consists of a range of studies including new systemic treatments, radiotherapy, CAR-T and bio-banking/observational providing a varied role for team members.
Working with a team of Clinical Trials Coordinators, Research Nurses, and Investigators you will support the delivery of commercial, NCRN and academic trials. We put emphasis on individual's and team's development and encourage engagement from all team members into meetings and system improvement projects. An exposure to a variety of trials, tasks and processes enables professional and continuous growth.
The role is ideal for individuals keen to pursue an administrative career in clinical trials coordination. It is tailored to equip the successful candidate(s) with the necessary skills and experience to become a future expert in this field.
Job description
Job responsibilities
The specific responsibilities will depend on the requirements of each team, but mayinclude: Act as a point of contact for the core Research and Development team, studysponsors, clinical research organisations and specific research teams,communicating directly with them regarding data queries, monitoring visitsand other enquiries relevant to trial set up and general trial conduct. Set up and initiation of allocated trials within an assigned team, under theguidance of the Senior Clinical Trials Coordinators. Track all payments throughout each clinical trial including completion ofactivity logs and requesting invoices to be raised. Maintain investigator site files and essential documentation in accordancewith ICH-GCP and Trust SOPs to ensure they are kept inspection ready at alltimes. Process trial amendment submissions in accordance with ICH-GCP and TrustSOPs 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, patientvisit logs, costing spreadsheets, case report form trackers and electronicproformas). Produce trial workbooks for review by the lead Clinical Research Nurse andPrincipal Investigator for assigned studies and ensure version control ismaintained. Ensure collection of clinical case notes for all patients, so that these areavailable as needed, for monitoring and audit purposes. Complete case report forms as per sponsor requirements, and liaise withclinical trial monitors to ensure the data sent is valid and their requirementsare met at site monitoring visits. Cross check, confirm data and complete query resolution with sponsors andthird parties in a timely manner. Completion of clinical trial specific databases with data from various sourcessuch as questionnaires, hospital records and other electronic and papersources.Clinical Trials Coordinator- Band 4 March 2023 Liaise with internal and external NHS staff regarding case notes, datacollection, archival tumour blocks, mortality data, and other general trialactivities, which may be confidential and sensitive in nature. Arrange shipping and delivery of relevant trial data and documents includingimport/export of tumour blocks, ECGs and copy scans. Arrange team and trial related meetings as required, producing minutes in atimely manner. Ensure that data is available and up to date for any meetings related to aclinical trial. If required attend project related meetings, investigator meetings (abroad orteleconferences, as necessary) to convey the relevant information to thestudy team. Assist with preparation for audit and inspections within assigned teams. Assist with trial document archiving by following the Trusts archivingguidelines. Ensure that office/ trial related supplies are adequate and assist with theordering process. Undertake general administrative tasks as delegated by managerialrepresentatives from the Research Division to contribute to the smoothrunning of the patient recruitment Teams. Demonstrates the agreed set of values and accountable for own attitude andbehaviour.
Job description
Job responsibilities
The specific responsibilities will depend on the requirements of each team, but mayinclude: Act as a point of contact for the core Research and Development team, studysponsors, clinical research organisations and specific research teams,communicating directly with them regarding data queries, monitoring visitsand other enquiries relevant to trial set up and general trial conduct. Set up and initiation of allocated trials within an assigned team, under theguidance of the Senior Clinical Trials Coordinators. Track all payments throughout each clinical trial including completion ofactivity logs and requesting invoices to be raised. Maintain investigator site files and essential documentation in accordancewith ICH-GCP and Trust SOPs to ensure they are kept inspection ready at alltimes. Process trial amendment submissions in accordance with ICH-GCP and TrustSOPs 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, patientvisit logs, costing spreadsheets, case report form trackers and electronicproformas). Produce trial workbooks for review by the lead Clinical Research Nurse andPrincipal Investigator for assigned studies and ensure version control ismaintained. Ensure collection of clinical case notes for all patients, so that these areavailable as needed, for monitoring and audit purposes. Complete case report forms as per sponsor requirements, and liaise withclinical trial monitors to ensure the data sent is valid and their requirementsare met at site monitoring visits. Cross check, confirm data and complete query resolution with sponsors andthird parties in a timely manner. Completion of clinical trial specific databases with data from various sourcessuch as questionnaires, hospital records and other electronic and papersources.Clinical Trials Coordinator- Band 4 March 2023 Liaise with internal and external NHS staff regarding case notes, datacollection, archival tumour blocks, mortality data, and other general trialactivities, which may be confidential and sensitive in nature. Arrange shipping and delivery of relevant trial data and documents includingimport/export of tumour blocks, ECGs and copy scans. Arrange team and trial related meetings as required, producing minutes in atimely manner. Ensure that data is available and up to date for any meetings related to aclinical trial. If required attend project related meetings, investigator meetings (abroad orteleconferences, as necessary) to convey the relevant information to thestudy team. Assist with preparation for audit and inspections within assigned teams. Assist with trial document archiving by following the Trusts archivingguidelines. Ensure that office/ trial related supplies are adequate and assist with theordering process. Undertake general administrative tasks as delegated by managerialrepresentatives from the Research Division to contribute to the smoothrunning of the patient recruitment Teams. Demonstrates the agreed set of values and accountable for own attitude andbehaviour.
Person Specification
Qualifications
Essential
- Diploma or administration experience.
Desirable
- Degree in a science or health related discipline.
- Relevant training courses in clinical research.
- Qualification in computing or information technology /Relevant IT experience
Experience
Essential
- Relevant experience within a Good Clinical Practice and research environment.
Desirable
- Experience of working within a clinical trials environment.
- Relevant experience within a Good Clinical Practice and research environment.
Skills
Essential
- Good written communication 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
Desirable
- Good understanding and demonstrated use of the full Microsoft Office suite.
Knowledge
Essential
- Knowledge of the clinical trials process.
- Familiar with GCP guidelines/EU directives
Desirable
- Understanding of medical terminology and cancer.
- Understanding of case report forms.
- Knowledge of clinical Governance.
- Knowledge of patient information systems.
Values
Essential
- Ability to demonstrate the organisational values and behaviours
Other
Essential
- 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.
Desirable
- Ability to troubleshoot effectively
Person Specification
Qualifications
Essential
- Diploma or administration experience.
Desirable
- Degree in a science or health related discipline.
- Relevant training courses in clinical research.
- Qualification in computing or information technology /Relevant IT experience
Experience
Essential
- Relevant experience within a Good Clinical Practice and research environment.
Desirable
- Experience of working within a clinical trials environment.
- Relevant experience within a Good Clinical Practice and research environment.
Skills
Essential
- Good written communication 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
Desirable
- Good understanding and demonstrated use of the full Microsoft Office suite.
Knowledge
Essential
- Knowledge of the clinical trials process.
- Familiar with GCP guidelines/EU directives
Desirable
- Understanding of medical terminology and cancer.
- Understanding of case report forms.
- Knowledge of clinical Governance.
- Knowledge of patient information systems.
Values
Essential
- Ability to demonstrate the organisational values and behaviours
Other
Essential
- 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.
Desirable
- 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.
