JOB DESCRIPTION
Job Title Research Data Officer
Pay Band Band 4
Department Research and Development
Division Corporate
Reports to Research Coordinator/ Quality Assurance Officer
Professionally Senior Research Nurse & Deputy Clinical Managers
Responsible to
JOB SUMMARY
The post holder will be a key member of the NIHR/Wellcome Trust Clinical Research Facility (CRF)
research team and responsible for supporting research staff. Specific responsibilities include
providing data management and research administrative support, as needed for all clinical trials
activities in all areas of the CRF. The post holder will take a lead role in developing database
applications for new clinical studies and registries of research patients for local and national research
projects. This will require the post holder to combine their IT knowledge with knowledge of the
clinical research process.
TEAM/DEPARTMENT STRUCTURE CHART
Data Team Structure
Deputy non-clinical
manager
Research QA Officer
Coordinator
Senior Data Officer
Data Officer Data Officer Data Officer
Basic overall CRF structure
Laboratory Deputy manager Deputy clinical
manager manager
Laboratory staff Nursing team
Data team Admin team
KEY SKILLS
The post holder is required to work on their own initiative on a regular basis and manage their own
workload; this will require excellent planning and organisational skills. The post holder must be able
to communicate information to a wide range of staff group including consultants and external
stakeholders. The post holder is expected to develop a good understanding of research and
development tools and techniques.
Using their own judgement the post holder will be able to prioritise their work effectively.
KEY RESPONSIBILITIES
Study Set up
1. To assist with the acquisition and distribution of relevant trial documentation
2. To assist in the preparation of Research files
3. To establish” trial site files “ for each trial in accordance with ICH Good Clinical Practice (GCP) and
Research Governance
Ongoing studies
1. Collection of patient data from medical notes and completion of Case Report Forms (CRFs) and
liaise with Clinical Trial Officers, Research Nurses and Clinicians to ensure correct data collection
2. To transcribe /export data from medical records (paper or electronic) to CRFs (paper or electronic)
as required by the protocol
3. To check eligibility of patients into trials and to ensure that all relevant data has been recorded
4. To randomise /register patients to trials according to protocol requirements
5. To assist in ensuring that protocol required tests/procedures are done according to the schedule
in the specific protocol
6. To ensure safe filing and storage of study documentation and samples in accordance with ICH GCP
and Research Governance
7. Maintain sufficient stocks of documentation and equipment required for trials (e.g. CRFs,
Questionnaires, Blood sample kits)
8. To arrange couriering of samples as required by research protocol
9. To organise and prepare visits by trial monitors as required by protocol
10. To take responsibility for liaising with Clinical Trials Units regarding data queries and for checking
and resolving data queries
End of Study Responsibilities
1. To ensure study paperwork is filed correctly in accordance with the relevant CRF Standard
Operating Procedure (SOP)
2. To facilitate the secure storage of study documentation in accordance with ICH GCP and Research
Governance
Administration
1. To carry out general clerical and office management duties within the office and maintain an
efficient filing system
2. To ensure compliance within the Network and Host Trusts policy on data protection,
confidentiality and security
Communication
1. To communicate effectively with all disciplines of staff involved in the research study
2. To liaise with outside research agencies such Clinical Trial Units, University Clinical Trials Unit and
Medical Research Council regarding individual research studies
3. To deal sensitively and in a professional manner on the telephone
Other
1. Understand and adhere to Trust policies and procedures
2. This position may require travel to Research Units outside the hospital environment
3. To undertake an annual appraisal (internal performance review) to identify
organisational and professional objectives and development needs
The post holder will undertake other duties as may be required to achieve the
Trust’s objectives, commensurate with the grading of the post.
BUDGETARY AND RESOURCE MANAGEMENT
None
MANAGEMENT , SUPERVISORY, TEACHING, TRAINING RESPONSIBILITIES
Act as a resource for colleagues in relation to clinical trials.
The post holder is to continue his/her own professional development keeping updated with current
practice in research
RESEARCH AND DEVELOPMENT
The post holder will work within the Research, Development & Innovation department, and will be
directly involved with the administration of trials.
The post holder will be involved in internal audits and preparing for inspections & on occasion and
will be expected to assist in the analysis and interpretation of these audits.
EFFORT -
Physical Effort
Sitting at a desk using a computer for prolonged periods. Other activities include meetings and
walking to other areas of the Trust. The post holder will also need to go into clinical areas to
complete their clinical tasks.
Mental Effort
There is a frequent requirement for prolonged concentration e.g. writing reports, using electronic
software packages e.g. Excel, Word, Project Manager.
Emotional Effort
Exposure to sensitive information in relation to research patients and confidential research projects.
TRUST VISION & VALUES
DO NOT AMEND THIS SECTION
The Trust is clear on its vision and values and aims to make sure that they are reflected in all areas of
activity. Our vision is simple; building healthier lives. Our values apply to every member of staff and
help us in all we do and how we do it. They are:
Kind: The kindness that people show to each other every day
Connected: The connections we build with everyone around us
Bold: The ability to be bold in how we think, speak and act
ADDITIONAL INFORMATION
This job description is designed to assist post holders with understanding what is expected of them
in their role. University Hospitals Birmingham NHS Foundation Trust may ask them to undertake
other duties, as required, which are not necessarily specified on the job description but which are
commensurate with the grade of the post.
The job description itself may be amended from time to time in consultation with the post holder,
within the scope and general level of responsibility attached to the post.
All post holders must take responsibility to ensure that they are aware of and adhere to all Trust
policies, procedures and guidelines relating to their employment regardless of their position within
the Trust.
Last Updated: ………………………………………………………….
PERSON SPECIFICATION
JOB TITLE: B4 Research Data Officer
TRAINING, QUALIFICATIONS AND PROFESSIONAL REGISTRATIONS
ESSENTIAL DESIRABLE
GCSE in Maths and English or
equivalent
Education to A level or equivalent
experience
Experience in undertaking a range of
work procedures
EXPERIENCE & KNOWLEDGE
ESSENTIAL DESIRABLE
Evidence of administrative or clinical Knowledge of medical terminology
audit experience in an NHS setting or Awareness of Research Governance as far
similar experience as it affects collection of research Study
Evidence of a methodical approach data
and effective organisational skills
Working knowledge of patient
confidentiality / Caldicott guidelines
SKILLS & ABILITY
ESSENTIAL DESIRABLE
Well-developed IT skills including use
of Microsoft Office software and
email.
Experienced user of databases and
reporting tools and ability to update
skills as necessary.
Ability to work under own initiative
and to prioritise and manage own
workload.
Ability to work to deadlines and under
pressure.
Accurate and attentive to detail.
Motivated and able and willing to
learn.
Excellent numerical and written skills.
Able to produce reports and graphs
for internal and external audit
purposes as required.
Able to work independently and as
part of a team.
Excellent communication skills.
Ability to seek out information when
not readily available
OTHER SPECIFIC REQUIREMENT
ESSENTIAL DESIRABLE
Ability to work under pressure,
prioritise workloads and meet tight
deadlines
Proactive and able to work on own
initiative
Enthusiastic and self-motivated
Ability to demonstrate integrity and
common sense
A proven problem solving ability
Good communication skills
Team player
