We are seeking an enthusiastic, motivated and experienced individual who will be responsible for assisting a team of Clinical Trials Coordinators, Research Nurses, and Investigators with various aspects of clinical trial administration/ coordination. You will support the delivery of commercial, non-commercial and academic trials with a focus on early phase trials. Full training in all processes will be provided and an exposure to a variety of trials, tasks and processes enables professional and continuous growth
Applicants should meet all the essential criteria on job description as a minimum. We are looking for a candidate with good organisational and communication skills, administration experience and knowledge of clinical trials/GCP.
Applicants should meet all the essential criteria described in the job description as a minimum.
You will be trained on GCP and NHS research standards and be responsible for data management, case report form completion, invoicing, communication with trial sponsors, monitors and the wider research community, maintaining electronic records to support the team and assisting with the set-up of new studies.
You will be liaising with many different members of staff including internal service departments, central R&I office colleagues, 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.
Please see the attached job description for a more detailed description of the tasks this job will involve.
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.
As a key member of the haematology research team, you will be joining a busy, dynamic and supportive group who are passionate about clinical trials. The research landscape is constantly evolving and our 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.
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 a wide range of necessary skills and experience.
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
- 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 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.
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