Clinical Trials Coordinator

3 weeks ago

Manchester, United Kingdom The Christie NHS Foundation Trust Full time

Please note that this post is offered as a fixed term contract for 12 months in the first instance at 37.5 h/week.

An exciting opportunity has arisen within the Research and Innovation Division at The Christie.

We are looking to appoint a Clinical Trials Coordinator to the Lung Cancer clinical research delivery team within The Christie NHS Foundation Trust. We are seeking an enthusiastic and highly motivated individual, who has a keen interest, and some experience preferably, in clinical research.

Key skills required are excellent organisation and communication skills, and an ability to work well both in a team and using their own initiative.

Applicants should meet all the essential criteria described in the job description as a minimum, including a good understanding of the clinical trials process, and previous data management and administrative experience.

I would strongly encourage interested applicants to contact the team to further discuss the role and how you can become a key member of this exemplary team.

The focus of this role is to support the clinical research team by providing a high quality clerical and administrative service according to ICH-Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.

The role will involve all aspects of clinical trial management, including setting up trials, invoicing, case report form completion, maintaining electronic records to support the team and amendment processing.

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.

We are a team that strives to develop our staff to the best of their potential and are keen for all members of our team to continue to learn and share knowledge.

The Christie Lung Cancer Research Team vision is to build upon our reputation as a local and national leader in clinical trial delivery. Pursuing exemplary care and prioritising the safety and experience of our clinical research participants, carried out by a highly trained and passionate clinical research team. By becoming a member of the Lung Research Team, you will be joining a dynamic and supportive team who are constantly striving to improve ourselves by working collaboratively across the nursing, medical and administrative teams.

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 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 Investigators 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 w

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