Research Data Coordinator

Job overview

The post holder will be responsible for the provision of high-quality data coordination in a dynamic clinical trials team, providing efficient and organised administrative support to the members of the Haematology Research Unit (HRU). The post holder will ensure confidential and sensitive information is kept secure at all times.

The post holder will work independently and follow the policies and procedures for the trust and within the unit. The post holder will also be expected to use their own initiative and report accordingly to their line manager and senior colleagues.

This role is within a busy research unit, subject to frequent deadlines for a large portfolio of clinical trials as such, the post holder will need to possess excellent time management and planning skills.

The post holder will work closely with the Principal Investigators and Consultants, the HRU Research Nurses and Trial Coordinators, medical staff, and clinical trials sponsors and representatives.

The post holder will ensure consistent and professional administrative and data support to the

HRU and support the team’s agreed portfolio of commercial and non-commercial clinical trials. This will require flexibility, the use of initiative and a very high degree of organisational skills.

Main duties of the job

• ensure data is collected in line with protocol requirements, complying to the principles of GCP, national and local policies
• work at all times according to regulations described in local Standard Operating Procedures and EU Clinical Directive
• ensure data is entered into paper or electronic Case Report Forms (CRF) accurately and in a timely manner
• Track CRF completion including the number of outstanding CRFs at any one time
• ensure data integrity is maintained at all times and to raise any issues with the quality or the collection of data with line management or senior colleagues
• proactively follow up with missing or unclear data
• request for any external lab results, reports or any discharge summaries or GP correspondence etc. pertinent to a patients involvement in a clinical trial
• assist with data cleaning exercises, where required
• help design, where required, data capture worksheets to aid data collection in busy clinical settings
• engage with clinicians and ward staff, where required, to ensure satisfactory data collection from colleagues outside of the usual research team e.g. out of hours, unscheduled admissions
• ensure protocol and CRF entry training is completed in advance of trial activation from Sponsor
• ensure delegation logs are signed and authorised before any trial related activity commences

Detailed job description and main responsibilities

• To assist with maintaining Investigator Site Files and source documentation
• To assist with recruitment accrual uploads on to the UKCRN portal / EDGE
• To participate in internal audits as well as assist with the preparation of external audits or inspections by Sponsor or the MHRA
• To ensure Serious Adverse Events are recorded and reported in accordance with the protocol and/or sponsor’s SOP within 24 hours of notification
• To assist with the archiving of trial documentation at the end of study
• To assist in ad hoc tasks to support the development of the HRU and with various projects and events
• To arrange and provide administrative support for meetings, including minute taking and transcribing minutes of team meetings, where required
• To deal with telephone calls from patients and stakeholders and be responsive to any requests
• To disseminate information to consultants regarding new trials to enable optimal patient recruitment
• To explain, disseminate and collect patient quality of life questionnaires

Trial support

• To support the research nurses / clinical trial coordinators in the collection of protocol required blood samples (phlebotomy training will be provided)
• To be responsible for collecting (from clinic/wards), processing and shipping trial related samples to central laboratories ensuring compliance with processing requirements in the study specific lab manuals
• To ensure all central lab kits are available, within date, and re-ordered when stock is low, in a timely manner
• To attend multi-disciplinary team (MDT) meetings and assist in identifying potentially suitable patients for entry into clinical trials by screening patient clinic notes

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.