Regulatory Compliance Officer for Living Laboratory Research

3 weeks ago

Glasgow, Glasgow City, United Kingdom University of Glasgow Full time
Job Purpose

The role is essential for ensuring the Living Laboratory adheres to the UK Policy Framework for Health and Social Care Research, the Medicines for Human Use (Clinical Trials) Regulations, UK data regulations, the Human Tissue Act, and other pertinent standards.

The individual in this position will play a crucial role in supporting, implementing, and overseeing the governance frameworks associated with clinical research within the Living Laboratory, ensuring that all research activities align with the procedures established by the University's Research Regulation and Compliance team.

Acting as the primary liaison for research personnel and students, senior management, and the broader research community, the post holder will provide expert guidance and information regarding research involving human subjects, their tissues, or data.

Main Duties and Responsibilities 1.

Serve as the main contact within the Research Regulation & Compliance team for inquiries related to Living Laboratory research, delivering comprehensive support and guidance for an expanding and complex research portfolio.

2. Review research protocols in collaboration with NHS and University colleagues, offering expert advice and support both verbally and in writing regarding research governance. 3.

Assist in enhancing the University/NHS Digi trial capabilities by reviewing, providing expert guidance, and granting sponsor approval for trial-related documentation submitted to regulatory authorities and research ethics committees.

4.

Contribute to the development of artificial intelligence studies, including large language and foundational models, ensuring compliance with regulatory standards and safety protocols.

5. Identify, document, and effectively manage clinical and research-related risks. 6.

Coordinate, plan, prioritize, and execute sponsor trial-related research activities, resulting in the creation of robust documentation for timely submissions to regulatory and ethical bodies in the UK.

7. Determine, in consultation with NHS and University colleagues, when the University should sponsor or co-sponsor a clinical study. 8.

Ensure compliance with the General Data Protection Regulation (GDPR) in the collection and storage of personal data. Assist staff working with the Living Laboratory in obtaining NHS Research Passports, including determining the necessary level of pre-engagement checks (e.g., criminal record/occupational health) and Occupational Health requirements.

10. Utilize expert knowledge to write, develop, and maintain standard operating procedures and quality management systems within the Living Laboratory. 11.

Collaborate with business development colleagues within the Living Laboratory to ensure that both commercial and non-commercial research proposals can be effectively supported and managed within the University's compliance frameworks.

These key tasks are not exhaustive but highlight several major responsibilities that the staff member may reasonably be expected to perform.

Knowledge, Qualifications, Skills and Experience Knowledge/Qualifications Essential A1 Scottish Credit and Qualification Framework level 9, or an Ordinary/Honours Degree, Post Graduate Qualification, or equivalent in a relevant subject discipline. A2 Basic understanding of research project/trial management and execution.
A3 Familiarity with the regulatory framework governing research involving human subjects.
A4 Working knowledge of the Integrated Research Application System.
A5 Understanding of UK, EU, and international data protection legislation.

A6 Demonstrable knowledge of NHS research support services and organizations, including Safe Havens and Biorepositories, and their operational procedures related to higher education institutions.

Desirable B1 Professional qualification in a relevant field.
B2 Good understanding of the UK/Scotland trial landscape, including both academic and commercial research.
B3 Knowledge and understanding of the Higher Education sector, ideally including medical, veterinary, and life sciences.
B4 Functional understanding of UK/EU Medical Device Legislation. Skills Essential C1 Demonstrable, structured approach to project/trial management, including reporting skills.

C2 Experience and ability to collaborate across a range of organizations, including academia, the NHS, or other public bodies, and/or commercial entities.

C3 Ability to perform under pressure while maintaining collaborative principles and meeting challenging deadlines.
C4 A motivated individual accustomed to using initiative, skills, and creativity to resolve issues and establish priorities.
C5 Capacity to multitask, work flexibly, and adapt to changing environments.
C6 Excellent written and verbal communication skills. Experience Essential E1 Relevant experience in the establishment or delivery of innovative health-related projects/trials.
E2 Engaging with research teams and ensuring the successful delivery of projects to meet key targets.
E3 Evidence of planning, managing, and delivering research projects within a health research context.

Please Note: If you are a current employee of the University of Glasgow, please be advised that the University would consider an internal secondment opportunity for this post. University of Glasgow applicants should seek clearance for release for internal secondment from their line manager before making a formal application. Terms and Conditions Salary will be Grade 7, £39,347 - £44,263 per annum. This post is full time (35 hours per week) and fixed term for up to 12 months in the first instance. As part of Team UofG you will be a member of a world-changing, inclusive community that values ambition, excellence, integrity, and curiosity. The University of Glasgow has a responsibility to ensure that all employees are eligible to live and work in the UK. If you require a Skilled Worker visa to work in the UK, you will be required to meet the eligibility requirements of the visa route to be assigned a Certificate of Sponsorship.

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