Clinical Trial Coordinator Manchester, England
Job description
An exciting opportunity has arisen within the Research and Innovation Division at The Christie. We are looking to appoint a Developmental Clinical Trials Coordinator to the Pan Tumour clinical research delivery team within The Christie NHS Foundation Trust.
We are seeking enthusiastic and highly motivated individuals, who are ableto demonstrate some experience in clinical trials coordination and/or data management involving clinical trials or project co-ordination, with an understanding of clinical research.
We are looking for individualswith excellent organisation and communication skills, who can work well both in a team and using their own initiative.
The role is ideal for individuals wishing to work in clinical research as it will allow a broad experience of NHS clinical research.
Applicants should meet all the essential criteria described in the job description as a minimum, including holding a scientific or business-based degree, or have relevant experience in scientific and medical research.
The focus of these roles is to provide support to sustain and improve an excellent level of service provision from a trial site perspective for our research partners. In order to support our growth as a centre of excellence in research, a tailored training programme will be provided to the successful candidates to consolidate the skills required to support our delivery of clinical research.
We are looking for individuals who will act as a key co-ordinator for a number of clinical trials within the Pan Tumour Research portfolio and support the provision of a high quality and efficient administrative service.
The role will involve aspects of work within clinical trials which may include, clinical trial data entry, invoicing, study coordination. Workload assignment will vary and not all aspects of the job description will be performed.
Opportunities will be available to lead service development projects within the team.
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.
The Pan Tumour 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 Pan Tumour 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.
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.
I would strongly encourage interested applicants to contact the team to further discuss the roles and how you can become a key member of this exemplary team
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 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.
