This is a unique and exciting opportunity for anenthusiastic and motivated individual to join the Research Team of Fylde CoastClinical Research (FCCR), which is embedded within Layton Medical Centre, anNHS GP Practice in Blackpool.
Recognised as a national leader in recruitment to PhaseII/III clinical trials across a broad range of therapeutic areas and designatedan NIHR Primary Care Commercial Research Delivery Centre , you will be workingin a fast-paced environment with our research participants at the heart ofeverything we do. We are looking to appoint a Clinical Trial Coordinator to theResearch team who will be responsible for assisting the PrincipalInvestigators, research nurses, and trial coordination team with variousaspects 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 responsibilities
The post holder will assist with the administration ofclinical trials from feasibility to archiving including (but not limited to):
Main duties of the job
Assist with the efficient and timely set up ofclinical trials.
Communicate directly with participants and assistwith tracking of their appointments including
Manage own workload for daily trial activityincluding data entry and support with amendment processing to meet internal andexternal deadlines.
Assist with quality assurance of all trialrelated documentation in accordance with relevant legislation and guidelines.
Assist with preparation for audit andinspections
General trial-related communication inaccordance with the Data Protection Act.
Key Responsibilities
Act as a point of contact for the teamcommunicating directly with them regarding participant appointments, dataqueries, monitoring visits and other enquiries relevant to trial set up andgeneral trial conduct.
Support the set up and initiation of studies, underthe guidance of the senior team
Track participant visits, updating core researchsystems including the completion of enrolment and recruitment activity logs
Maintain electronic and physical investigatorsite files and essential documentation in accordance with ICH-GCP and FCCR SOPsto ensure they are kept inspection ready at all times
With support, process trial amendmentsubmissions in accordance with ICH-GCP and FCCR SOPs and timelines.
Provide general administrative support to the teamas and when required
Support the completion of study worksheets whenrequired maintaining appropriate version control
Ensure timely collection of participant medicalhistories, so that these are available as needed for visits and monitoringpurposes
When required liaise with clinical trialmonitors to ensure the data is valid and their requirements are met at sitemonitoring visits.
Completion of clinical trial specific databaseswith data from various sources
With support, cross check, confirm and complete dataquery resolution in a timely manner.
Arrange shipping and delivery of relevant trialdata, supplies and documents when required
Support the arrangement of team and trialrelated meetings as required, producing minutes in a timely manner.
Ensure that data is available and up to date forany meetings related to a clinical trial.
If required attend project related meetings toconvey the relevant information to the study team.
Assist with preparation for audit andinspections within the FCCR team
Assist with trial document archiving
Ensure that trial related supplies (includingblood kit supplies) are adequate andassist with the ordering process when required
Administrative and Governance Responsibilities
Maintainaccurate and confidential participant records.
Ensurecompliance with data protection and confidentiality standards.
Contributeto audit, service evaluation, and quality improvement initiatives
Attendresearch meetings as required.
Qualifications
- Diploma or administrative experience
- Degree in a science or health related discipline.
Experience
- Experience in administration including data management
- Good understanding and demonstrated use of Microsoft Word/ Excel
- Accuracy and attention to detail
- Good organisational skills.
- Good interpersonal skills.
- Good oral communication skills
- Relevant training courses in clinical research.
- 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.
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