Job summary
An exciting opportunity has arisen for an administrator to work within the NIHR Sheffield Clinical Research Facility.
As a Data Co-ordinator the post holder will work closely with Research Nurses and Principal Investigators and their teams to input sound accurate data for participants taking part in clinical research/experimental medicine trials. In addition they will have responsibility for maintaining trial documentation to regulatory, governance and GCP requirements. The post holder is expected to display meticulous attention to detail and undertake trial specific training on all existing and new data collection systems whether electronic or paper. All study related activity must be completed to Good Clinical Practice (GCP) legislation.
Please note: Interviews will be held face to face at the Royal Hallamshire Hospital, Sheffield.
Main duties of the job
- Collect and enter data into electronic or paper Case Report Forms (CRF) from source data files and medical records.
- Follow trial specific instructions and Standard Operating Procedures for data entry.
- Ensure all data entered in a meticulous manner with attention to detail.
- Ensure all data entry complies with legislation and Good Clinical Practice (GCP) requirements.
- Validate and interpret data from medical notes for CRF completion.
- Acquire additional clinical trial data from hospital computer systems, GPs, external hospitals and organisations in compliance with information governance.
- Responsible for working to CRF, Sponsor Standard Operating Procedures and Trust Policies.
- Understand and work to the Data Protection Act and the Trusts Information Governance Policy.
- Understand and work to the Trusts Information Governance Policy.
- Maintain patient and research confidentiality.
- Liaise with all members of the multidisciplinary team to ensure the smooth and efficient running of trials.
About us
You will be working for an organisation which values and respects all of its staff and the community it serves. The Trust is a leader in the NHS and research sectors and provides excellent benefits for its staff. This includes commitments to professional development but also many policies to support employees in balancing their personal and professional lives.
The NIHR Sheffield Clinical Research Facility is a joint venture between the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust. Use of the facility is available to all clinical researchers and provides a specialist environment for the conduct of high quality clinical research. The CRF staff, both clinical and non-clinical, work with investigators to ensure research carried out in the CRF is of the highest possible standard and adheres to Research Governance and the Regulatory Framework.
The CRF is based across the two main acute sites of the Trust, the Royal Hallamshire Hospital (RHH) and the Northern General Hospital (NGH). The RHH site opened in September 2006 with the NGH site opening in September 2009. Both sites provide access to highly skilled research nurse and admin support to Investigators across all clinical areas.
Job description
Job responsibilities
Please view the attached Job Description and Person Specification documents for full details regarding this post.
When completing your application please ensure that you clearly demonstrate how you meet the role criteria.
Job description
Job responsibilities
Please view the attached Job Description and Person Specification documents for full details regarding this post.
When completing your application please ensure that you clearly demonstrate how you meet the role criteria.
Person Specification
Personal Qualities
Essential
- Effective interpersonal skills
Skills and Knowledge
Essential
- Excellent verbal and written communication skills
- Methodical accurate approach to working with excellent attention to detail
- Highly organised with excellent time management skills and ability to work to deadlines
- Ability to work well as part of a team as well as individually
- Knowledge of clinical trial process
- Understanding of medical/scientific terminology
Experience
Essential
- Administrative experience
- Experience of entering data into a variety of systems
- Experience of working independently
- Experience of filing and collating records
- Experience of Microsoft Office, (including, Excel, Powerpoint, Outlook, Word)
- Experience of managing a diverse workload
Desirable
- Experience of working in a healthcare setting
- Experience of working in a Research setting
Education and Qualifications
Essential
- Educated to A Level or equivalent qualification/experience.
- GCSE English and Maths at Grade 4/C or above or equivalent qualification/experience.
- NVQIII in an IT related field or equivalent qualification/experience
- Good Clinical Practice (GCP) certificate or equivalent demonstrable experience
Desirable
- Science or specific data analysis qualification
Person Specification
Personal Qualities
Essential
- Effective interpersonal skills
Skills and Knowledge
Essential
- Excellent verbal and written communication skills
- Methodical accurate approach to working with excellent attention to detail
- Highly organised with excellent time management skills and ability to work to deadlines
- Ability to work well as part of a team as well as individually
- Knowledge of clinical trial process
- Understanding of medical/scientific terminology
Experience
Essential
- Administrative experience
- Experience of entering data into a variety of systems
- Experience of working independently
- Experience of filing and collating records
- Experience of Microsoft Office, (including, Excel, Powerpoint, Outlook, Word)
- Experience of managing a diverse workload
Desirable
- Experience of working in a healthcare setting
- Experience of working in a Research setting
Education and Qualifications
Essential
- Educated to A Level or equivalent qualification/experience.
- GCSE English and Maths at Grade 4/C or above or equivalent qualification/experience.
- NVQIII in an IT related field or equivalent qualification/experience
- Good Clinical Practice (GCP) certificate or equivalent demonstrable experience
Desirable
- Science or specific data analysis qualification
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
