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Band 8A - Regulatory Compliance Manager

Employer
Royal Free London NHS Foundation Trust
Location
London
Salary
£58,698 to £65,095 per annum inclusive of HCAS
Closing date
19 Jul 2024

View more

Profession
Other Health Profession
Grade
Band 8A
Contract Type
Permanent
Hours
Full Time
An exciting opportunity has arisen for an exceptional individual to be appointed as the Research Compliance Manager within the growing R& D Office at the Royal Free Hospital.

The successful applicant will have excellent interpersonal and written communication skills, be practical, methodical and organised.

Main duties of the job

The main duties of this job will enable the Trust to Sponsor regulated studies underpins the Trust tripartite ambition to deliver leading healthcare treatment, ground- breaking clinical research and teaching excellence and in line with the 5-year R& D strategy.

The role will enable the Trust to sponsor regulated studies at RFL which aims to maximise opportunities for the organisation and ensure reputational benefits. The job will build on RFL's international reputation for research and expand our capacity to conduct complex and higher risk experimental research. This enhanced research infrastructure is expected to attract the next generation of aspiring academics and establish RFL as one of the UK's leading centres for clinical and translational research.

About us

The R& D Office operates agile working for staff members and places the Trust's values at the heart of how we conduct our relationships with our staff, patients and stakeholders.

Job description

Job responsibilities

The post holder will have a key role in co-ordinating working practices and policy implementation, ensuring the Trust is compliant with internal Standard Operating Procedures (SOPs), polices and external regulatory frameworks at all times.

The post holder will coordinate all necessary preparation for external audit and regulatory inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA) on RFL Sponsored regulated studies.

The post holder will also be one of the nominated delegated research archivists for the department and will be required to ensure that this process is performed according to regulatory standards and trust R& D processes for all Sponsored regulated trials conducted and will undertake routine auditing of these systems and processes.

The post holder may also be expected to spend a proportion of their time assisting with trial coordination, and thus may be required to take full responsibility for the management and coordination of several clinical trials, based on workload and business needs.

For the full job description and responsibilities please refer to the PS and JD.

Person Specification

Knowledge and Qualifications

Essential

  • First degree or equivalent in clinical or life science related subject
  • Evidence of further education including post graduate certificate/diploma/CPD in clinical research
  • Good knowledge of research frameworks and legal acts underpinning these
  • Knowledge of local, national and international developments in clinical research policy


Desirable

  • Formal training/ certification in Quality Management and/or monitoring clinical trials


QMS and Experience

Essential

  • Significant experience of undertaking, co-ordinating or managing clinical research
  • Experience of developing and implementing QA procedures for regulated studies in a clinical research environment.
  • Experience of undergoing an inspection and audit by an external authority


Desirable

  • Experience of managing QA systems for clinical trials in Phases I, II and Ill
  • Experience of providing training in GCP/GLP
  • Experience of working in the NHS


Skills and Abilities

Essential

  • Excellent communication skills
  • Ability to interpret complex information to facilitate change
  • Confident in making autonomous professional decisions relating to QA
  • Good negotiating skills and the ability to influence others at all levels to initiate change


Employer details

Employer name

Royal Free London NHS Foundation Trust

Address

Royal Free London

Pond Street

London

NW3 2QG

Any attachments will be accessible after you click to apply.

391-RFL-6419264

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