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Band 8A - Regulatory Compliance Manager

Applications are closed

  • Job
    Full-time
    Senior Level
  • London

Requirements

  • - Excellent interpersonal and written communication skills
  • - Practical, methodical, and organised
  • - Previous applicants need not apply
  • - Ensure the Trust is compliant with internal Standard Operating Procedures (SOPs), policies and external regulatory frameworks at all times
  • - Coordinate all necessary preparation for external audit and regulatory inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA) on RFL Sponsored regulated studies
  • - Be one of the nominated delegated research archivists for the department and ensure that this process is performed according to regulatory standards and trust R&D processes for all Sponsored regulated trials conducted
  • - Undertake routine auditing of these systems and processes
  • - May also be expected to spend a proportion of their time assisting with trial coordination
  • - May be required to take full responsibility for the management and coordination of several clinical trials, based on workload and business needs

Responsibilities

  • - Co-ordinating working practices and policy implementation, ensuring the Trust is compliant with internal Standard Operating Procedures (SOPs), policies and external regulatory frameworks at all times.
  • - Coordinate all necessary preparation for external audit and regulatory inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA) on RFL Sponsored regulated studies.
  • - Ensure that the process of research archiving is performed according to regulatory standards and trust R&D processes for all Sponsored regulated trials conducted and undertake routine auditing of these systems and processes.
  • - Assist with trial coordination and may be required to take full responsibility for the management and coordination of several clinical trials, based on workload and business needs.

FAQs

What is the job title for this position?

The job title is Band 8A - Regulatory Compliance Manager.

Where is this position located?

This position is located at the Royal Free Hospital within the R&D Office.

What are the main responsibilities of the Regulatory Compliance Manager?

The main responsibilities include coordinating compliance with internal SOPs and external regulatory frameworks, preparing for external audits, and maintaining research archive standards for sponsored regulated studies.

What skills are required for this role?

Excellent interpersonal and written communication skills, along with being practical, methodical, and organized are required for this role.

Is previous application experience necessary for this position?

No, previous applicants need not apply for this position.

Will the role involve trial coordination?

Yes, the post holder may be required to assist with trial coordination and manage several clinical trials based on workload and business needs.

How does the role contribute to the Trust’s goals?

This role supports the Trust’s ambition to deliver leading healthcare treatment, groundbreaking clinical research, and teaching excellence by enabling the Trust to sponsor regulated studies.

What type of working environment is promoted by the R&D Office?

The R&D Office operates an agile working environment for staff and places the Trust's values at the center of its relationships with staff, patients, and stakeholders.

Will the post holder be involved in audits and inspections?

Yes, the post holder will coordinate preparation for external audits and regulatory inspections by the MHRA for RFL Sponsored regulated studies.

What is the focus of the R&D strategy mentioned in the job description?

The focus of the R&D strategy is to enhance research infrastructure, attract aspiring academics, and establish RFL as a leading center for clinical and translational research.

Delivering world class expertise at Barnet, Chase Farm and the Royal Free hospitals. We represent the NHS at its best.

Science & Healthcare
Industry
10,001+
Employees
1828
Founded Year

Mission & Purpose

Today, the Royal Free London NHS Foundation Trust runs three London hospitals; Barnet Hospital in north London, Chase Farm Hospital in Enfield and the Royal Free Hospital in Hampstead. Barnet Hospital and Chase Farm Hospital became part of the Royal Free London NHS Foundation Trust on 1 July 2014. Last year our highly skilled healthcare teams provided treatment and care for over a million patients and achieved some of the best clinical outcomes in England. Our mortality rates have been the best among England's hospital trusts for many years. Our goal is to continue excelling and to be in the top 10 per cent in the UK for clinical research, scientific medical research and teaching outcomes. We provide a wide range of routine and specialist health services and we aim to deliver world class healthcare to our patients. To do so, we combine world class expertise with leading healthcare that is local, patient-focused and friendly.