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Clinical Research Compliance Coordinator

2 months ago


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

The primary aim of this role is to ensure adherence to the UK Policy Framework for Health and Social Care Research, alongside compliance with the Medicines for Human Use (Clinical Trials) Regulations, UK data protection laws, the Human Tissue Act, and other pertinent regulations.

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 protocols established by the University's Research Regulation and Compliance team.

This role will serve as the main point of contact for research personnel and students, senior management, and the broader research community, offering guidance and information regarding research involving human subjects, their tissues, or data.

Key Responsibilities 1.

Act as the primary liaison within the Research Regulation & Compliance team for inquiries related to Living Laboratory research, providing thorough guidance and support for an expanding and complex research portfolio.

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

Assist in advancing the University/NHS Digi trial capabilities by reviewing, providing expert guidance, and approving trial-related documentation for submission to regulatory bodies and research ethics committees.

4.

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

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

Coordinate, plan, prioritize, and execute sponsor-related research activities, producing comprehensive 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 that personal data is collected and stored in accordance with the General Data Protection Regulation (GDPR). Assist staff in obtaining NHS Research Passports, including assessing the necessary 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 to ensure that both commercial and non-commercial research proposals are supported and managed within the compliance frameworks of the University.

The responsibilities outlined above are not exhaustive but highlight key tasks expected of the staff member.

Knowledge, Qualifications, Skills, and Experience Essential Knowledge/Qualifications A1. A degree at Scottish Credit and Qualification Framework level 9, or an equivalent qualification in a relevant discipline. A2. Fundamental understanding of research project and trial management. A3. Knowledge of the regulatory framework governing research involving human subjects. A4. Familiarity with the Integrated Research Application System. A5. Understanding of UK, EU, and international data protection laws.

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

Desirable Qualifications B1. Professional qualification in a relevant field. B2. Strong understanding of the UK/Scotland trial landscape, including both academic and commercial research. B3. Familiarity with the Higher Education sector, particularly in medical, veterinary, and life sciences. B4. Basic understanding of UK/EU Medical Device Legislation. Essential Skills C1. Demonstrated structured approach to project and trial management, including reporting capabilities.

C2. Experience collaborating across various organizations, including academia, NHS, or commercial entities.

C3. Ability to work effectively under pressure while maintaining collaborative principles and meeting deadlines.
C4. Self-motivated individual capable of using initiative, skills, and creativity to solve problems and prioritize tasks.
C5. Ability to multitask, adapt to changing environments, and work flexibly.
C6. Excellent written and verbal communication skills. Essential Experience E1. Relevant experience in setting up or delivering innovative health-related projects or trials.
E2. Proven ability to engage with research teams and ensure project delivery to meet key objectives.
E3. Evidence of planning, managing, and delivering research projects within a health research context.

Please Note: Current employees of the University of Glasgow may be considered for an internal secondment opportunity for this position. Applicants should seek clearance for release for internal secondment from their line manager before making a formal application.

Terms and Conditions Salary will be at Grade 7, ranging from £39,347 to £44,263 per annum. This position is full-time (35 hours per week) and fixed-term for an initial period of 12 months. As part of Team UofG, you will be part of a world-changing, inclusive community that values ambition, excellence, integrity, and curiosity. The University of Glasgow is committed to ensuring 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 must meet the eligibility requirements of the visa route to be assigned a Certificate of Sponsorship.