About this role
Job summary
This is a unique and exciting opportunity for an enthusiastic and motivated individual to join the Research Team of Fylde Coast Clinical Research (FCCR), which is embedded within Layton Medical Centre, an NHS GP Practice in Blackpool.
Recognised as a national leader in recruitment to Phase II/III clinical trials across a broad range of therapeutic areas and designated an NIHR Primary Care Commercial Research Delivery Centre , you will be working in a fast-paced environment with our research participants at the heart of everything we do. We are looking to appoint a Clinical Trial Coordinator to the Research team who will be responsible for assisting the Principal Investigators, research nurses, and trial coordination team with various aspects of clinical trial administration/ coordination.
Main duties of the job
If successful the Clinical Trials Coordinator will be responsible for arranging research appointments, data entry, case report form completion, communication with monitors when required, maintaining electronic trackers/research systems and supporting the team by assisting with the set-up of new studies.
You will be liaising with different members of the research team aswell as study participants/carers so good communication and interpersonal skills are key. Within this role the postholder will ensure adherence to Good Clinical Practice (GCP), study protocols, FCCR Standard Operating Procedures and NHS Research Governance frameworks.
The postholder will work within a supportive, flexible environment and will be provided with training and development opportunities as well as access to NHS standard benefits including the NHS Pension. You will become part of a dynamic team who continue to push the boundaries supporting the successful delivery of clinical research across the NHS in the UK.
We are an award-winning Research Site and notably in 2023 won the PharmaTimes Clinical Site Team of the Year Gold Award.
About us
For the right candidate you will work within a supportive environment and will be provided with a full suite of research training. You will also have access to NHS standard benefits including the NHS Pension .
Job description Job responsibilities
The post holder will assist with the administration of clinical trials from feasibility to archiving including (but not limited to):
Main duties of the job
Assist with the efficient and timely set up of clinical trials.
Communicate directly with participants and assist with tracking of their appointments including
Manage own workload for daily trial activity including data entry and support with amendment processing to meet internal and external deadlines.
Assist with quality assurance of all trial related documentation in accordance with relevant legislation and guidelines.
Assist with preparation for audit and inspections
General trial-related communication in accordance with the Data Protection Act.
Key Responsibilities
Act as a point of contact for the team communicating directly with them regarding participant appointments, data queries, monitoring visits and other enquiries relevant to trial set up and general trial conduct.
Support the set up and initiation of studies, under the guidance of the senior team
Track participant visits, updating core research systems including the completion of enrolment and recruitment activity logs
Maintain electronic and physical investigator site files and essential documentation in accordance with ICH-GCP and FCCR SOPs to ensure they are kept inspection ready at all times
With support, process trial amendment submissions in accordance with ICH-GCP and FCCR SOPs and timelines.
Provide general administrative support to the team as and when required
Support the completion of study worksheets when required maintaining appropriate version control
Ensure timely collection of participant medical histories, so that these are available as needed for visits and monitoring purposes
When required liaise with clinical trial monitors to ensure the data is valid and their requirements are met at site monitoring visits.
Completion of clinical trial specific databases with data from various sources
With support, cross check, confirm and complete data query resolution in a timely manner.
Arrange shipping and delivery of relevant trial data, supplies and documents when required
Support the arrangement of 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 to convey the relevant information to the study team.
Assist with preparation for audit and inspections within the FCCR team
Assist with trial document archiving
Ensure that trial related supplies (including blood kit supplies) are adequate and assist with the ordering process when required
Administrative and Governance Responsibilities
Maintain accurate and confidential participant records.
Ensure compliance with data protection and confidentiality standards.
Contribute to audit, service evaluation, and quality improvement initiatives
Attend research meetings as required.
Person Specification
Qualifications Essential
Diploma or administrative experience
Desirable
Degree in a science or health related discipline.
Experience Essential
Experience in administration including data management Good written communication skills. Good understanding and demonstrated use of Microsoft Word/ Excel Accuracy and attention to detail Good organisational skills. Good interpersonal skills. Good oral communication skills
Desirable
Relevant training courses in clinical research. Relevant IT experience Experience of working within a clinical trials environment. Relevant experience within a Good Clinical Practice and research environment Good understanding and demonstrated use of the full Microsoft Office suite.
Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Employer details Employer name Layton Medical Centre
Address 200 Kingscote Drive
Blackpool
FY3 7EN
United Kingdom
Employer's website https://www.laytonmedicalcentre.co.uk/ (Opens in a new tab)