Amendments Officer

Job overview

An exciting opportunity has arisen for an amendments officer with clinical trial assistant duties to work as part of the Cancer Research Delivery Group (CRDG) at the Barts Centre for Experimental Cancer Medicine (CECM).

The post-holder will work within the multi-disciplinary team as an amendments officer with Clinical Trial Assistant (CTA) duties.  It is anticipated that there will be a roughly 50:50 split although this may be adjusted according to the workloads.

Main duties of the job

• Assist the Amendments Officer with the co-ordination and implementation of Cancer amendments: o    Manage and process cancer study amendments in line with country regulations and internal SOPs o    Maintain tracking of process through Excel based trackers and other database systems (EDGE) o    Work closely with supporting departments o    Communicate with Sponsor and internal teams •    Accurately collect and record essential trial information being mutually supportive and covering duties as necessary during colleagues’ absences and at times of additional pressure. o    Collection of clinical data on Case Report Forms  o    Maintenance of a database of trial activity  o    Maintaining site files and processing amendments  o    Ensuring that the trials are run according to current national law; local guidelines and procedures; following the principles of Good Clinical Practice (GCP)

Detailed job description and main responsibilities

We are seeking an enthusiastic individual with high levels of attention to detail and is energised by working in a challenging and fast paced environment. The candidate will work within a highly effective team and should have good IT and communication skills. Experience of clinical trials is essential.

The successful candidate will have previous experience in an administrative background ideally within an NHS or research setting. You must provide demonstrable IT skills, including: e-mail, word processing and databases, along with attention to detail and high standards of accuracy with the ability to follow instructions. Previous experience of clinical data entry and familiarity with Good Clinical Practice (GCP) and the regulatory environment that surrounds clinical research would be an advantage. We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager.

The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents, please view the attachment/s below.