Job summary
As a Clinical Trials Administrator, you main role will be to assist the NIHR LCRF team with all aspects of administration related to clinical trials according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
You will provide administrative support to the NIHR LCRF who currently undertake a range of trial activity for various disease group including cancer including tracking participants, completing case report forms, assisting in the set up of new trials and ongoing administrative management of existing trials.
You will be joining a small and friendly team , well organised but busy environment, you will be key to the efficient running of the NIHR LCRF, providing clinical trials to our patients. We strive for outstanding care for our patients and deliver novel treatments in an early phase setting for patients in the north west.
Main duties of the job
To undertake general administrative duties and maintain electronic and paper filing systems as required in support of the NIHR LCRF team, also collating trial specific activities for commercial studies on a spread sheet in order to assist the finance personnel to make payments to individual hospital departments when required.
To accurately transcribe patient data, including medications, toxicities and adverse events from medical records into paper or electronic case record forms (CRFS) and other trial documents and obtain counter-signatures as required according to Good Clinical Practice.
To liaise with trial sponsors/co-ordinating centres to ensure accurate and timely reporting of clinical trial data and to resolve data queries with assistance from clinical staff as required.
About us
We have 9000 fantastic people working hard to deliver quality services to our patients. Whatever your role, you help look after 370,000 people in our local area & give specialist care to 1.5 million people across Lancashire & Cumbria.
Working with us gives you the knowledge and sense of pride that every activity you do genuinely does make a difference to support our patients & staff, ensuring we keep thriving & delivering outstanding healthcare right across our local towns.
You'll have access to varied development opportunities, learn new skills, meet fab people & do things you'd never have done. You'll learn about working in a hospital, interacting with people from all different roles to build skills & enhance your career path.
You'll make an impact, be challenged to think differently, be bold & help innovate to keep improving things. Everything we do centres around patient care and enhancing their experience which means your role is pivotal and something really to be proud of.
Job description
Job responsibilities
- To undertake general administrative duties and maintain electronic and paper filing systems as required in support of the team, also collating trial specific activities for commercial studies on a spread sheet/invoicing system
- Assist the finance personnel with the invoicing of activity for research trials conducted within the LCRF when required
- Supporting research practitioners with the preparation of patient visits, making sure paperwork is prepared in advance of the appointment.
- Retrieve investigation results for review by the clinical team as required collection and dispatching of CDS provided by radiology organising couriers, transmission via web base of certain investigations
- To ensure relevant data is recorded in accordance with the requirements of the trial protocol.
- To assist with the acquisition and distribution of trial documentation and to establish a trial site file for each trial in accordance with ICH Good Clinical Practice (GCP) and research governance.
- To ensure all relevant information is available to enable clinical staff to assess patient eligibility against a trial protocol
- To accurately transcribe patient data, including medications, toxicities and adverse events from medical records into paper or electronic case record forms (CRFS) and other trial documents and obtain counter-signatures as required according to Good Clinical Practice
- To liaise with trial sponsors/co-ordinating centres to ensure accurate and timely reporting of clinical trial data and to resolve data queries with assistance from clinical staff as required
- Adhering to Trust and appropriate trial sponsor standard operating procedures
- Working as part of the LCRF team to provide support whilst managing own workload across a wide range of specialities including cancer. The line manager will direct the workload and the postholder is expected to be able to prioritise assigned tasks and act on own their initiative
- Liaising closely with support services in supporting the feasibility process. Attend and contribute to team meetings
- The post holder may be also required to work on badged studies from the NIHR Manchester Bio Resource Centre (BRC)
- Communicate clearly with colleagues, keeping the team updated on things such as trial management workload, monitoring visits, and passing on messages and emails appropriately. Organisation of meetings and booking rooms appropriately
- Lead on day to day trial administration for the team, flagging any issues or barriers to this with the senior research nurse
- To organise and prepare visits with trial monitors as required by the protocol, including close-out of clinical trials ensuring all documents are present following the Archiving SOP
- Responding promptly to requests for information to support local and national reporting obligations of the Trust as required and contributing to communication materials including activity reports, presentations, posters and newsletters throughout the Trust.
- Actively participating in the PDPR (Personal development and performance review) process as a reviewee
- The post holder will be pro-active in monitoring working practices within the LCRF team, identifying best practice and suggesting any improvements to administration processes
- Identifying and addressing any research training needs working in partnership with the LCRF team and wider R&I team
- Be involved with the processing of patient samples alongside preparation and shipping of the samples. This will include arrangement of shipment and tracking of samples.
- Post holders are expected to work a flexible work pattern as the service needs dictate, which may also involve the post holder to work across different teams within R&I.
Job description
Job responsibilities
- To undertake general administrative duties and maintain electronic and paper filing systems as required in support of the team, also collating trial specific activities for commercial studies on a spread sheet/invoicing system
- Assist the finance personnel with the invoicing of activity for research trials conducted within the LCRF when required
- Supporting research practitioners with the preparation of patient visits, making sure paperwork is prepared in advance of the appointment.
- Retrieve investigation results for review by the clinical team as required collection and dispatching of CDS provided by radiology organising couriers, transmission via web base of certain investigations
- To ensure relevant data is recorded in accordance with the requirements of the trial protocol.
- To assist with the acquisition and distribution of trial documentation and to establish a trial site file for each trial in accordance with ICH Good Clinical Practice (GCP) and research governance.
- To ensure all relevant information is available to enable clinical staff to assess patient eligibility against a trial protocol
- To accurately transcribe patient data, including medications, toxicities and adverse events from medical records into paper or electronic case record forms (CRFS) and other trial documents and obtain counter-signatures as required according to Good Clinical Practice
- To liaise with trial sponsors/co-ordinating centres to ensure accurate and timely reporting of clinical trial data and to resolve data queries with assistance from clinical staff as required
- Adhering to Trust and appropriate trial sponsor standard operating procedures
- Working as part of the LCRF team to provide support whilst managing own workload across a wide range of specialities including cancer. The line manager will direct the workload and the postholder is expected to be able to prioritise assigned tasks and act on own their initiative
- Liaising closely with support services in supporting the feasibility process. Attend and contribute to team meetings
- The post holder may be also required to work on badged studies from the NIHR Manchester Bio Resource Centre (BRC)
- Communicate clearly with colleagues, keeping the team updated on things such as trial management workload, monitoring visits, and passing on messages and emails appropriately. Organisation of meetings and booking rooms appropriately
- Lead on day to day trial administration for the team, flagging any issues or barriers to this with the senior research nurse
- To organise and prepare visits with trial monitors as required by the protocol, including close-out of clinical trials ensuring all documents are present following the Archiving SOP
- Responding promptly to requests for information to support local and national reporting obligations of the Trust as required and contributing to communication materials including activity reports, presentations, posters and newsletters throughout the Trust.
- Actively participating in the PDPR (Personal development and performance review) process as a reviewee
- The post holder will be pro-active in monitoring working practices within the LCRF team, identifying best practice and suggesting any improvements to administration processes
- Identifying and addressing any research training needs working in partnership with the LCRF team and wider R&I team
- Be involved with the processing of patient samples alongside preparation and shipping of the samples. This will include arrangement of shipment and tracking of samples.
- Post holders are expected to work a flexible work pattern as the service needs dictate, which may also involve the post holder to work across different teams within R&I.
Person Specification
Education and Qualifications
Essential
- GCSE in Maths and English Grade C or above
- Educated to A level or equivalent experience
Desirable
- Science or health related degree
- Evidence of continuing professional development
Knowledge and Experience
Essential
- Experience of clinical trial data management and administration skills in a health services environment or in other administrative capacity
- Working knowledge of patient confidentiality/Caldicott guidelines
- Experience of interpreting medical data
- Experience of using databases
- Taking notes and recording information accurately
- Experience in undertaking a range of work procedures
Desirable
- Previous experience in oncology research
- Understanding of Research Governance and related legislation and guidelines
- Knowledge of medical terminology
Person Specification
Education and Qualifications
Essential
- GCSE in Maths and English Grade C or above
- Educated to A level or equivalent experience
Desirable
- Science or health related degree
- Evidence of continuing professional development
Knowledge and Experience
Essential
- Experience of clinical trial data management and administration skills in a health services environment or in other administrative capacity
- Working knowledge of patient confidentiality/Caldicott guidelines
- Experience of interpreting medical data
- Experience of using databases
- Taking notes and recording information accurately
- Experience in undertaking a range of work procedures
Desirable
- Previous experience in oncology research
- Understanding of Research Governance and related legislation and guidelines
- Knowledge of medical terminology
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.
