Job summary
There are 2 posts advertised to work as a Clinical Research Data Co-ordinator, within either the NIHR Sheffield Clinical Research Facility (CRF) or the Clinical Trials Assistant (CTA) Team.
The post holders will work closely with the team and Principal Investigators to provide sound accurate clinical research data entry for participants taking part in clinical research/experimental medicine trials. In addition, they will have responsibility for maintaining all clinical trial documentation to regulatory, governance and Good Clinical Practice (GCP) requirements.
The post holders are expected to display meticulous attention to detail, accuracy 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 GCP legislation
Main duties of the job
Collect and enter data into electronic or paper Case Report Forms (CRF) from source data.
Follow trial protocols.
Ensure all data is entered in a meticulous manner with attention to detail.
Ensure all data entry complies with legislation and Good Clinical Practice (GCP) requirements.
Acquire additional clinical trial data from hospital computer systems, GPs, external hospitals and organisations in compliance with information governance.
Work to STH, CRF and Sponsor Standard Operating Procedures and STH Policies.
Understand and work to the Data Protection Act and STH 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. STH 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 (CRF) is a specialised and dedicated research environment, with a cross-site nursing and administrative workforce. The CRF support NIHR Sheffield Biomedical Research Centre (BRC) Experimental Medicine studies.
The CTA Team is a cross site, directorate-based team. We are affiliated with both the CRF and BRC.
Both teams are based at Royal Hallamshire Hospital (RHH) and the Northern General Hospital (NGH).
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
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
- Ability to follow complex protocols and work to Standard Operating Procedures (SOPs)
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 or experience)
- GCSE English and Maths (or equivalent qualification or experience) at Grade 4/C or above
- NVQIII in an IT related field or (or equivalent qualification or experience)
- Clinical Practice (GCP) certificate or equivalent demonstrable experience
Desirable
- Science or specific data anyalysis qualification
Person Specification
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
- Ability to follow complex protocols and work to Standard Operating Procedures (SOPs)
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 or experience)
- GCSE English and Maths (or equivalent qualification or experience) at Grade 4/C or above
- NVQIII in an IT related field or (or equivalent qualification or experience)
- Clinical Practice (GCP) certificate or equivalent demonstrable experience
Desirable
- Science or specific data anyalysis 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).
