Clinical Research Data Coordinator

3 weeks ago


Sheffield, United Kingdom Sheffield Teaching Hospitals NHS Foundation Trust Full time

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.

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.

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 ProtectionAct 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.

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) 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

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