Clinical Trials Coordinator
Job overview
The main purpose of the role is to provide comprehensive data management and administrative support to the Lung Clinical Trials Team according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
The successful post holder will have experience working within clinical trial delivery within an NHS site and preferably an understanding of oncology research.
Main duties of the job
The post holder will:
- Manage and maintain the clinical trials database.
- Assist with the efficient and timely set up of clinical trials.
- Assist with the tracking and raising of invoices.
- Provide support with maintenance and quality assurance of all trial related documentation in accordance with relevant legislation and guidelines.
- Assist with preparation for audit and inspections within assigned teams.
- General trial-related communication in accordance with the Data Protection Act.
- Assist with maintenance of clinical trial documentation.
- Manage own workload for daily trial activity including case report form completion and amendment processing to meet internal and external deadlines
Working for our organisation
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.
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 work 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.
Detailed job description and main 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.
Person specification
Qualifications
Essential criteria- Diploma or administration experience.
- Degree in a science or health related discipline.
- Relevant training courses in clinical research.
- Qualification in computing or information technology /Relevant IT experience
Experience
Essential criteria- Experience in administration including data management.
- Experience of working within a clinical trials environment.
- Relevant experience within a Good Clinical Practice and research environment.
Skills
Essential criteria- Good written communication skills.
- Good understanding and demonstrated use of Microsoft Word and Excel.
- Accuracy and attention to detail
- Good organisational skills.
- Good interpersonal skills
- Good oral communication skills
- Good understanding and demonstrated use of the full Microsoft Office suite.
Knowledge
Essential criteria- Knowledge of the clinical trials process.
- Familiar with GCP guidelines/EU directives
- Understanding of medical terminology and cancer.
- Understanding of case report forms.
- Knowledge of clinical Governance.
- Knowledge of patient information systems.
Values
Essential criteria- Ability to demonstrate the organisational values and behaviours
Other
Essential criteria- Ability to work to tight and/or unexpected deadlines.
- Flexible with ability to adapt to service requirements.
- Hardworking; ability to manage a busy workload.
- Ability to work unsupervised or as part of a team.
- Tactful and diplomatic.
- Ability to troubleshoot effectively
The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.
We want to ensure that everyone who works at the Christie or uses our services is welcomed, valued and treated with dignity and respect. The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels.In support of these commitments, we particularly welcome applications from Black, Asian and other ethnic minority people and people with disabilities for this post. Appointment will be only on merit.
We are committed to creating a balanced and diverse workforce. As such we welcome and encourage applications from people of all backgrounds. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.
As users of the disability confident scheme, we guarantee to interview all disabled applicants who meet the minimum criteria for the vacancy
All positions within the Christie are subject to the receipt of satisfactory written references, medical clearance and evidence of your Right to Work in the UK. Some roles will require a Disclosure & Barring Service (DBS) check. Please note if you are successfully appointed to a post with this Trust, you will be required to pay for your own DBS Disclosure.
By applying for this post you are agreeing to The Christie NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job information will also be transferred into the national NHS Electronic Staff Records system.Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.
If you have not heard from us within four weeks of the closing date, I regret that on this occasion your application will have been unsuccessful.
The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and will form part of the recruitment process. In the event that you are successful following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.
Overseas candidates wishing to apply for this position and who would require immigration sponsorship, may wish to self-assess the likelihood of obtaining a Certificate of Sponsorship for the post on the UKVI website.
You should be aware the Trust operates a No Smoking Policy and therefore employees are not permitted to smoke at work.