Administrative Assistant (Quality)

University of Southampton; Southampton; Hybrid; GBP 25,000 - 30,000; Full time

Job summary

A UK university in Southampton is seeking an Administrative Assistant for their Quality and Regulatory Team. The role involves liaising with clinical research teams, maintaining quality documents, and establishing new systems. Strong communication and organizational skills are required. Knowledge of Good Clinical Practice is a plus. This full-time position offers a hybrid working model with flexible hours.

Qualifications

• Ability to follow standard procedures and enter information accurately.
• Knowledge of Good Clinical Practice (GCP) and clinical trial regulations is desirable.

Responsibilities

• Liaison with internal and external clinical research teams.
• Tracking, reporting and filing of quality documents.
• Setting up new systems to complement those already in place.

Skills

Strong English communication skills

Attention to detail

Strong organizational skills

Job description

Are you looking to take your first steps into the world of clinical research? We have a vacancy for an Administrative Assistant to join the Quality and Regulatory Team here at the Southampton Clinical Trials Unit (SCTU).

The SCTU, is based on the Southampton General Hospital site and manages a growing portfolio of multi-centre clinical trials that will directly influence routine clinical practice and benefit patients.

Ensuring that clinical trials meet high regulatory standards and prioritising patient safety is integral to the running of the SCTU. Your role will be in maintaining and developing vital quality and regulatory systems. Tasks will include:

Responsibilities

• Liaison with internal and external clinical research teams
• Tracking, reporting and filing of quality documents, supporting pharmacovigilance tasks
• Setting up new systems to complement those already in place

The successful applicant must have strong English communication skills, with excellent attention to detail including high standards of accuracy. They will be able to demonstrate strong organisational skills with the knowledge and ability to understand and rationalise problems. The right candidate should be able to follow standard procedures and enter information accurately into in-house databases. Knowledge of Good Clinical Practice (GCP) and clinical trial regulations is desirable, although full training will be given to the right candidate.

The Southampton Clinical Trials Unit is a UKCRC registered CTU and is part of a strong research environment in Southampton. We are located within the state-of-the-art Centre for Cancer Immunology building at Southampton General Hospital.

Additional Information

This full-time position is available on a 24-month fixed term contract in the first instance. Part time hours (minimum 0.8FTE) will be considered and discussed at interview stage. The SCTU is a hybrid working environment with a minimum of 3 days in the office (pro-rata) and a flexible approach to working from home, which can be discussed at interview.

For an informal discussion please contact Sara Yeats, Head of Quality Assurance, [e-mail]