Senior Data Clerk

3 weeks ago

Nottingham, United Kingdom Nottingham University Hospitals NHS Trust Full time

You will be a valued member of the busy Research & Innovation Department working closely with the research delivery team and external stakeholders to oversee data management.

The function of a senior data clerk is to oversee and interpret complex commercial and non-commercial data management, and enter accurate data onto remote data entry systems into pre-formatted clinical report forms and review prior to submission to Sponsor organisations.

This is a great opportunity for an individual to join an exciting and innovative research department. The post holder must have excellent communication and time management skills and be able to organise their own and workload within research time frames.

The role will be based In Oncology Research

To be main point of contact with Sponsors for data related activity including management of onsite and virtual monitoring visits and review of site file maintenance. Have a responsibility for a wide range of cross specialty trials which vary to each specific protocol

The post holder will receive and check documentation, access hospital patient information systems, confirm source data and resolve queries in a timely manner. To liaise with the trial caseholder to ensure data integrity prior to submission and data lock.

To liaise with and manage organising visits from external trial monitors, including obtaining patient records, scan results etc. in liaison with the research team.

To respond to data queries in a timely manner and escalate to trial case holders and principal investigators when necessary.

To review trial data information requirements prior to trial start up and attend other appropriate trial related meetings. Ensure that site files are accurately compiled and complete prior to greenlight initiation.

To have a good knowledge of all clinical trials taking place in the research team, both those to which patients are currently being recruited (open) and those, which are no longer recruiting patients (closed and in follow up).

Adhere to codes of practice covering confidentiality, data protection and ICH-GCP.

Every day, our teams at Nottingham University Hospitals NHS Trust (NUH) make a difference. We save lives, we improve lives and we usher in new life. We are proud to play a central role in supporting the health and wellbeing of people in Nottingham, Nottinghamshire and our surrounding communities.

We provide a range of national and internationally renowned specialist services and we are at the forefront of new surgical procedures and research programmes. We are home to the East Midlands Major Trauma Centre, the Nottingham Children's Hospital and in partnership with the University of Nottingham we host a Biomedical Research Centre carrying out vital research into hearing, digestive diseases, respiratory, musculoskeletal disease, mental health and imaging.

As a teaching hospital, we are instrumental in the education and training of doctors, nurses and other healthcare professionals. We are proud of our strong relationships with universities across the East Midlands, including the University of Nottingham, Nottingham Trent University and Loughborough University.

Data Collection

1. To review patient data from medical and nursing records and perform accurate completion of complex electronic case reports forms working to ICH GCP and research governance guidelines.

1. To be responsible for additional clinical trial data from other departments and external organisations.

1. To liaise with the research team, medical staff and the wider MDT to obtain timely source data according to trial protocols.

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