Job summary
An exciting opportunity has arisen for an administrator to work within the NIHR Sheffield Clinical Research Facility. Applications are invited from exceptional individuals who are keen to work within a unit dedicated to facilitating and supporting world-class clinical research.
The CRF supports a wide and increasing portfolio of studies across a breadth of clinical specialities. It provides an excellent environment to develop research skills and provides an education and development programme for clinical researchers. The CRF has recently been awarded an NIHR grant to further develop Experimental Medicine in South Yorkshire.
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.
Main duties of the job
The post holder will provide a key supportive role to the clinical teams of the CRF, assisting in the delivery of timely, high quality data entry for a large portfolio of clinical research activity. Data entry will meet the exacting requirements of the regulatory bodies and will be managed in compliance with good clinical practice.
You will be able to work effectively as part of a team and possess effective communication skills both written and verbal. Experienced in the use of IT packages, you will play a key role in maintaining clinical trial documentation, possess a positive approach to working and excellent attention to detail.
About us
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.
Data Entry
- 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.
- Report all Serious Adverse Events; on the instruction of and under supervision of the Research Sister/Investigator team.
- Ensure all data is entered in a timely manner within 48hours of a participant visit occurring
- Be the first named contact for monitoring visits
- Facilitate monitoring visits from sponsor organisations
- Responsibility for ensuring all documents to be reviewed at monitoring visits are sourced and available for review
- Organise research staff to be available when monitoring visits are scheduled and arrange time with the monitors
- Be responsible for booking and confirming availability for monitoring visits including the organisation of adequate space.
- Respond to any data query relating to monitoring visits within 5 working days of the enquiry generation and until resolution
- Complete data entry to meet datalock deadlines
- In conjunction with other research staff, prepare proforma to ensure source data is collected at appropriate times according to the trial protocol.
- Work with the research team to prepare and review study documentation in preparation for Audit and Regulatory Inspection.
- Attend Site Initiation visits
- Attend Investigator meetings nationally and abroad as required.
- Attend and participate in trial close out visits.
Administrative
- Responsible for working to CRF, Sponsor Standard Operating Procedures and Trust Policies
- Understand and work to the Data Protection Act and
- 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
- Responsible for the maintenance of essential documents within the Investigator Site Files
- Responsible for filing results and correspondence in source data files and medical records
- Responsible for filing results in Case Report forms
- Responsible for preparing essential documentation for archiving
- Responsible for liaising with R&D/Research Sponsor to arrange archive
- Responsible for document retrieval following archiving
- Responsible for maintaining the system that tracks final destination of study documentation when leaving the CRF
- Responsible for maintaining the system that logs receipt of equipment brought into the CRF
- Responsible for timely and safe return of equipment to sponsor
- Provide cover for CRF Reception if required
Job description
Job responsibilities
Please view the attached Job Description and Person Specification documents for full details regarding this post.
Data Entry
- 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.
- Report all Serious Adverse Events; on the instruction of and under supervision of the Research Sister/Investigator team.
- Ensure all data is entered in a timely manner within 48hours of a participant visit occurring
- Be the first named contact for monitoring visits
- Facilitate monitoring visits from sponsor organisations
- Responsibility for ensuring all documents to be reviewed at monitoring visits are sourced and available for review
- Organise research staff to be available when monitoring visits are scheduled and arrange time with the monitors
- Be responsible for booking and confirming availability for monitoring visits including the organisation of adequate space.
- Respond to any data query relating to monitoring visits within 5 working days of the enquiry generation and until resolution
- Complete data entry to meet datalock deadlines
- In conjunction with other research staff, prepare proforma to ensure source data is collected at appropriate times according to the trial protocol.
- Work with the research team to prepare and review study documentation in preparation for Audit and Regulatory Inspection.
- Attend Site Initiation visits
- Attend Investigator meetings nationally and abroad as required.
- Attend and participate in trial close out visits.
Administrative
- Responsible for working to CRF, Sponsor Standard Operating Procedures and Trust Policies
- Understand and work to the Data Protection Act and
- 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
- Responsible for the maintenance of essential documents within the Investigator Site Files
- Responsible for filing results and correspondence in source data files and medical records
- Responsible for filing results in Case Report forms
- Responsible for preparing essential documentation for archiving
- Responsible for liaising with R&D/Research Sponsor to arrange archive
- Responsible for document retrieval following archiving
- Responsible for maintaining the system that tracks final destination of study documentation when leaving the CRF
- Responsible for maintaining the system that logs receipt of equipment brought into the CRF
- Responsible for timely and safe return of equipment to sponsor
- Provide cover for CRF Reception if required
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 follow complex protocols and work to Standard Operating Procedures (SOPs)
- 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
- Previous 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
- Previous experience of working in a healthcare setting
- Previous experience of working in a Research setting
Education and Qualifications
Essential
- Educated to A level (or equivalent)
- GCSE English and Maths ( or Equivalent) at Grade 4/C or above
- NVQIII in an IT related field or equivalent
- Good Clinical Practice (GCP) certificate or equivalent demonstratable experience
Desirable
- Science or specific data anyalysis 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 follow complex protocols and work to Standard Operating Procedures (SOPs)
- 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
- Previous 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
- Previous experience of working in a healthcare setting
- Previous experience of working in a Research setting
Education and Qualifications
Essential
- Educated to A level (or equivalent)
- GCSE English and Maths ( or Equivalent) at Grade 4/C or above
- NVQIII in an IT related field or equivalent
- Good Clinical Practice (GCP) certificate or equivalent demonstratable 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).
