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Clinical Trials Assistant
2 weeks ago
Please note that this post is offered as two part time contracts. 1.0 WTE (Whole Time Equivalent (37.5 hours) is available over 2 posts. It can be worked as a variety of options between the two successful candidates such as 2 x 0.43 WTE (16 hrs each) or 2 x 0.5 WTE hrs each) or a mixture of the two depending on what works for the candidates.
We are looking to appoint two individuals into a Clinical Trials Assistant position to join the lung research delivery team within The Christie NHS Foundation Trust on a part time contract to aid the team with clinical trial administrative tasks including but not limited to overall administrative and organisational tasks related to hosting clinical trials, site file management and archiving. Prior experience in clinical trials is not essential, as full training will be given.
We are seeking two enthusiastic and highly motivated individuals, who have an interest in clinical trials administration and looking to gain experience in a busy trial coordination team. The role will enable you to get an understanding of clinical research, ICHGCP and clinical trial governance. We are looking for individuals with passion for applying organisational skills to assist team with day-to-day clinical trial coordination, whilst using their interpersonal skills to communicate effectively with a range of internal and external collaborators.
Applicants should meet all the essential criteria described in the job description as a minimum.
The post holders will assist with the provision of a high quality and efficient administrative service. You will work with Clinical Trial Coordinators and Research Nurses on a wide aspects of clinical trials administration.
You will be required to help the team with set tasks according to the daily trials' activity. These may include assisting with general administration associated with maintenance of trial documentation and site files, archiving of completed trials, regular trial management including amendment processing and team communications, managing stock of laboratory kits and completing activity logs to enable invoices being raised.
You will be liaising with many different members of staff including internal service departments, central R&I office colleagues, specialist 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.
This is primarily an office-based role and involves liaising with team members and service departments located in various hospital buildings at Withington site.
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 Research and Development 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 general trial conduct.
- Assist with the general administrative duties associated with the set up and initiation of rials within an assigned team, under the supervision of the Senior Clinical Trials Coordinators.
- Assist with completion of activity logs to enable 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.
- Assist with the processing of trial amendment submissions in accordance with ICH GCP and Trust SOPs and timelines, under the supervision of the Senior Clinical Trials Coordinators.
- Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements, under the supervision of the Senior Clinical Trials Coordinators.
- Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas).
- Assist the Clinical Trials Coordinators with the development of trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator.
- 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. This will be under the supervision of the Senior Clinical Trials Coordinators.
- 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 in collaboration with the Senior Clinical Trials Coordinators.
- Attend project related meetings, investigator meetings (abroad or teleconferences, as necessary).
- Assist with general preparation for audit and inspections within assigned teams, under the direct supervision of the Senior Clinical Trials Coordinators and lead Clinical Research Nurse.
- Assist with trial document archiving by following the Trust's 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.
