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Clinical Research Data Coordinator
1 month ago
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.
As a Clinical Research Data Co-ordinator the post holder will work closely with Research Nurses and Principal Investigators and their teams to provide sound accurate clinical research data 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 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.
The post holder may be expected to travel nationally and internationally to attend investigator meetings and receive study specific training.
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.
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.
Please view the attached Job Description and Person Specification documents for full details regarding this post.
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