Clinical Trials Assistant - Wakefield, United Kingdom - The Mid Yorkshire Teaching NHS Trust

The Mid Yorkshire Teaching NHS Trust

Verified Company

Wakefield, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

The post holder will assist with the delivery of direct and indirect clinical research care in support of research studies.

The post holder is expected to complete general administrative duties associated with study set up, running and closing of a clinical trial including data collection, data entry and maintenance of essential documents.

Ensure all work undertaken, is in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP) to ensure provision of high-quality care.

The post holder will carry out assigned clinical duties under supervision of senior nursing staff and other relevant professional practitioners to provide a safe environment for the treatment of research participants.

To provide support to the Research team in the following areas; Patient support To assist in the identification of patient eligibility for studies/trials.

Liaise with other appropriate health care professionals Co-ordination of pre-study tests, obtaining results/X-Rays and arranging appropriate appointments as per clinical trial protocols To assist with the co-ordination of the patients journey through the clinical trial protocol e.g.

requisition and organisation of any necessary investigations. Team Working; To ensure that all members of the multidisciplinary team are aware of the current trials portfolio.

To provide feedback to Clinical teams on issues relating to recruitment, protocol amendments and trial results. The post holder will demonstrate the ability to manage their own administrative case-load, working as part of the team.

In conjunction with all members of the clinical trials team and appropriate healthcare professionals, develop a cohesive and flexible team working environment across the service.

Administration:
To assist the research teams in the formulation of documentation in preparation for ethical submission and R&D submission.

To assist the research team in setting up new studies/trials, ensuring site files are maintained in accordance to ICH GCP To be responsible for the collection and collation of trial data and completion of trial documentation in accordance with trial protocols.

To ensure that all quality-of-life assessments are completed in line with protocol requests. This may involve undertaking telephone assessments. To ensure that all trial data is submitted to the study sponsor within the specified time constraints.

To manage and respond to any data queries received. To maintain a monthly accrual list of all studies and distribute among the relevant members of the MDTs.

To report monthly accrual data on all patients recruited into studies highlighting local activities that might impact on achievement of targets.

To ensure all accrual data is inputted onto the recruitment database/electronic systems.

To be responsible for monitoring and ordering specific trial equipment and stationary. To assist in the planning and organising study feasibility meetings and site initiation meetings, involving internal and external teams. To take minutes and maintain documentation during trial management meetings or other related meetings. To assist in the writing of standard operating procedures.