Senior Clinical Trial Assistant

Job overview

An exciting opportunity has arisen to join The Royal Marsden Clinical Trials Unit as a Senior Clinical Trial Assistant in the RM-CTU Breast team. This is an ideal opportunity for a CTA looking to progress in their career and wishing to learn more about breast oncology trials from the sponsor perspective. You will join a team of experienced trial professionals, world class clinicians and scientists based in the Ralph Lauren Centre for Breast Cancer Research, and be a part of ground-breaking research into breast cancer treatments.

Flexible working hours and hybrid working in office/at home are supported in this team.

For further information and informal queries please contact:

Dymphna Lee, Lead Project Manager – RM-CTU Breast team [email protected]

Main duties of the job

• To support the clinical research team with study administration as required to ensure the efficient and successful delivery of clinical trials and other studies according to Good Clinical Practice (GCP), standard operating procedures (SOPs), trust policies and all applicable regulations and governance structures.
• To ensure timely and accurate entry of data and relevant information into appropriate database systems
• To work with the clinical team to ensure prompt resolution of data queries
• Responsibility for the day-to-day supervision, training and oversight of workload for the Clinical Trial Administrators (CTAs) to ensure data management is performed to required standards to meet all relevant SOPs and regulations.

Detailed job description and main responsibilities

For further information on this role, please see the attached detailed Job Description and Person Specification:

• To ensure that data collection and (electronic) case report form ((e)CRF) completion is performed to the required standards of the current EU, UK and FDA legislation, Trust SOPs and Sponsor contractual obligations.
• To design and implement tools and guidance for clinical trial data capture.
• To regularly report on data entry status to ensure deadlines are met for interim and final analysis.
• To represent the Data Management team at research meetings.
• To prepare and facilitate the archiving of essential clinical trial documents and source data as per Trust SOPs.
• To undertake projects with relation to office management as required.
• Tissue tracking using RMH systems (as applicable)
• Ensure that scans are uploaded to trial specific electronic portals where required.