Job summary
- Main area
- Clinical Research
- Grade
- Band 4
- Contract
- Permanent
- Hours
- Full time - 37.5 hours per week (8am - 4pm Monday to Friday)
- Job ref
- 411-RES-24-6241557
- Employer
- Alder Hey Children's NHS Foundation Trust
- Employer type
- NHS
- Site
- Clinical Research Facility
- Town
- Liverpool
- Salary
- £25,147 - £27,596 Per annum pro rata
- Salary period
- Yearly
- Closing
- 09/05/2024 23:59
Employer heading
Data Manager
Band 4
Alder Hey Children’s NHS Foundation Trust is a provider of specialist health care and has a presence in community outreach sites and, in collaboration with other providers, our clinicians help deliver care closer to patients’ homes by holding local clinics at locations from Cumbria to Shropshire, in Wales and the Isle of Man. The Trust also provides inpatient care for children with complex mental health needs at our Sunflower House building newly relocated, and opened on the hospital site.
We currently have more than 4,000 staff working across our community and hospital sites. We’re also a teaching and training hospital providing education and training to around 540 medical and over 500 nursing and allied health professional students each year.
As black and minority ethnic (BME) employees are currently under-represented in this area, we particularly welcome applications from members of our BME communities. All appointments will be made on merit.
You can expect a warm welcome at Alder Hey Childrens NHS Foundation Trust, our staff are friendly and welcoming. We listen to each other and work together to embed our Trusts values and behaviours. At Alder Hey we appreciate our staff and reward them with an outstanding benefits package including:
- Great flexible working opportunities
- Lease car scheme and Home Electronics Scheme
- Generous annual leave and pension scheme
- Extensive staff health and well-being programmes
Job overview
Data Manager
Band 4
37.5 Hours per week
The main purpose of the role is to support the clinical research team with all aspects of clinical trials administration, according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
The post-holder will be responsible for supporting the delivery of clinical trials within the Clinical Research Division from feasibility to archiving including (but not limited to):
- Assist with the efficient and timely set up of clinical trials
- Manage own workload for daily trial activity including case report form completion and 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 within assigned teams.
- General trial-related communication in accordance with the Data Protection Act.
- Assist with maintenance of clinical trial documentation.
- Completion of Case Report Forms (CRFs) ensuring all patient data is collected accurately.
- Responsible for reporting of any Serious Adverse Events (SAE) within required timeframe
- Assist with the tracking and raising of invoices.
- Direct contact with patients and families to support study visits.
Main duties of the job
The post-holder will be responsible for supporting the delivery of clinical trials from feasibility to archiving including (but not limited to):
- Assist with the efficient and timely set up of clinical trials
- Manage own workload for daily trial activity including case report form completion and 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 within assigned teams.
- General trial-related communication in accordance with the Data Protection Act.
- Assist with maintenance of clinical trial documentation.
- Completion of Case Report Forms (CRFs) ensuring all patient data is collected accurately.
- Responsible for reporting of any Serious Adverse Events (SAE) within required timeframe
- Assist with the tracking and raising of invoices.
- Direct contact with patients and families to support study visits.
Working for our organisation
Our values:
We pride ourselves on the quality of our care, going the extra mile to make Alder hey a safe and special place for children and their families.
We are committed to continually improving for the benefit of our patients.
We are open and honest and engage everyone we meet with a smile.
We show that we value every individual for who they are and their contribution.
We work across the Alder Hey community in teams that are built on friendship, dedication, care and reassurance.
Detailed job description and main responsibilities
- 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 Clinical Research Nurse Team Leader.
- Maintain investigator site files and essential documentation in accordance with ICH
- GCP and Trust SOPs to ensure they are always kept inspection ready.
- Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements.
- Ensure collection of clinical case notes for all patients for monitoring and audit purposes, arranging and securing access to electronic records for external monitoring visits.
- Study specific training for use of electronic databases/portals
- Completion of CRFs, data entry and data query resolution in a timely manner.
- Assist with preparation for audit and inspections.
- Attend and contribute to team and departmental meetings.
- 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 the Team Leader.
Person specification
Qualifications
Essential criteria
- Education to a minimum of GCSE standard or equivalent
Desirable criteria
- ECDL qualification Relevant training courses in clinical research
Experience
Essential criteria
- Previous research/data collection or clinical audit experience
Desirable criteria
- Experience of working within a health care system.
- Able to assess and interpret clinical/non-clinical information.
Knowledge
Essential criteria
- Knowledge of the clinical trials process.
- Familiar with GCP guidelines/EU directives
Desirable criteria
- Knowledge of issues relevant to paediatric research.
- Knowledge of patient information systems.
Skills
Essential criteria
- Good organisational skills
- Good verbal and written communication skills.
- Good verbal and written communication skills.
- Ability to work autonomously and as part of a team
- Good interpersonal skills
- Good attention to detail
Desirable criteria
- Experience of working with MS Office applications
- Ability to troubleshoot effectively.
Other
Essential criteria
- Ability to work to tight and/or unexpected deadlines.
- Flexible.
- Conscientious and hardworking.
Employer certification / accreditation badges
Applicant requirements
The postholder will have regular contact with vulnerable people and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.
Documents to download
Further details / informal visits contact
- Name
- Dawn Jones
- Job title
- Research Nurse Team Leader
- Email address
- [email protected]
- Telephone number
- 015 1252 5570
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