Research Regulatory Facilitator

SONICOM; Gloucester; On-site; GBP 36,000 - 50,000; Full time

Benefits offered by this job

41 days annual leave

Generous pension schemes

Flexible working policy

Cycle-to-work scheme

Season ticket loan

Job summary

Imperial College London is seeking a Research Regulatory Facilitator to join the Research Governance and Integrity Team, based primarily at White City Campus. You will support regulatory and administrative processes for clinical and non-NHS research, ensuring compliance with UK policies and regulations.

The role involves training development, project oversight, audits, and liaison with NHS Trusts, charities, and industry partners.

Qualifications

• Degree in health care, biological sciences or related discipline, or equivalent research experience.
• Experience with clinical trials/research in NHS/HEI environment and understanding of GCP.
• Strong organisational and communication skills.

Responsibilities

• Provide administrative oversight and liaison for sponsored healthcare research projects.
• Support initiation, protocol design, ethical review, indemnity and risk assessment.
• Assist with regulatory registration, training development and delivery.
• Conduct audits for regulatory and operational compliance and report CAPAs.
• Oversee monitoring, reporting and contract/funding approvals prior to research start.

Skills

Interpersonal skills

Time management

Education

Degree in health care or biological science

Job description

We have an exciting opportunity for a Research Regulatory Facilitator to join Imperial College London’s Research Governance and Integrity team. You will be based primarily at White City Campus.

You will report directly to the Research Governance and Integrity Manager, and work with them to ensure that all administrative processes relating to the development, initiation and management of clinical research are facilitated by the RGIT for the College/ICHT in line with the UK policy framework for health and social care and all research applicable regulations including the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). This role will form an important part of the RGITs training team and programme.

What you would be doing

• To support the Research Governance and Integrity Manager in providing administrative oversight, expert advice and liaison for all College/ICHT sponsored healthcare research projects and non-NHS human research projects, in particular the facilitation of:
• Project initiation
• Protocol design and review
• Ethical review
• Indemnity and risk assessment
• Regulatory registration and compliance
• Training development and delivery
• Project oversight, audit and monitoring
• Tracking and management of Serious Adverse Events
• To provide administrative and operational support, in partnership with the Joint Research Office, to ensure that healthcare research is managed in line with the sponsorship requirements and regulations
• Act on own initiative to oversee research applications (including non-NHS based research) and approvals in line with organisational operational procedures
• To ensure monitoring and reporting arrangements are adhered to
• Accurate authorisation and interpretation (where applicable) of contracts, funding proposals and grants and act as a gatekeeper to final approvals prior to commencement of research studies
• Ensure funding requirements are met prior to project approval.
• Provide specialist advice and training support for researchers across the Trust and College requiring clinical trials and research governance support in the College/ICHT
• Act as a liaison between the College/ICHT and its partners and collaborators in NHS Trusts, Charities, Research Councils, pharmaceutical and other industrial companies
• Develop materials for and present training workshops, courses and classes to Trust and College researchers, support teams and students relating to research management, organisational procedures and governance requirements
• Promote, contribute to and support the work of the RGIT and the training it provides
• Provide advice and training to researchers and administrators relating to clinical research governance and local procedures and assist the Research Governance and Integrity Manager in overseeing the College/ICHT research portfolio
• To maintain awareness of the legal, ethical (and funding) frameworks for healthcare and interpretations/changes therein as they relate to the College/ICHT’s healthcare research activity and role of the research sponsor
• Conduct audits of clinical research within the College/ICHT and NHS Trust collaborators to assess regulatory and operational compliance, including review of patient records. To also audit systems, processes and vendors. To write audit reports and follow these up to resolution, including review of corrective actions and preventative actions plans (CAPAs) and to lead on audits with appropriate training
• Assist in the review, development, implementation and compliance with RGIT Standard Operational Procedures
• Responsible for the maintenance of the clinical trial database and management of periodic reports for all ICHT/College research projects
• To assist the Research Governance and Integrity Manager and Head of Research Governance and Integrity in collating data on ICHT/College research activity
• Be actively involved and support the development of research governance systems for the College/ICHT
• To advise Investigators in developing research protocols and study documents in line with regulations. To ensure that appropriate peer review is in place
• Review ongoing research projects for continued compliance with organisational and regulatory requirements
• Oversee the research approval mechanisms for the Trust and College in support of the Research Governance Manager
• Deputise for the Research Governance and Integrity Manager in their absence

What we are looking for

Those wishing to apply will have a degree in the area of health care, biological science or a related discipline, or equivalent research experience and will have experience of clinical trials/research in an NHS Trust and/or Higher Education Institute (HEI) environment, an in-depth understanding of clinical research regulations, quality assurance, research governance and the principles of Good Clinical Practice (GCP). Candidates must have excellent interpersonal skills, attention to detail and be highly organised.

The role is in a dedicated team, within a challenging and rewarding environment so candidates must have good time-management skills and demonstrate a strong team-work ethic. Applicants should be committed to continuous professional development in research to ensure that the RGIT are delivering an excellent service to the researchers of the University and NHS Trust.

What we can offer you

• The opportunity to continue your career at a world-leading institution and be part of our mission to use science for humanity.
• Benefit from a sector-leading salary and remuneration package (including 41 days’ annual leave and generous pension schemes).
• Access to a range of workplace benefits including a flexible working policy from day one, generous family leave packages, on-site leisure facilities and cycle-to-work scheme.
• Interest-free season ticket loan schemes for travel.
• Be part of a diverse, inclusive and collaborative work culture with various staff networks and resources to support your personal and professional wellbeing .

Further information

This is a full-time post (35 hours per week).

Attached documents are available under links. Clicking a document link will initialize its download.

Please note that job descriptions are not exhaustive, and you may be asked to take on additional duties that align with the key responsibilities mentioned above.

We reserve the right to close the advert prior to the closing date stated, should we receive a high volume of applications. It is therefore advisable that you submit your application as early as possible to avoid disappointment.

If you encounter any technical issues while applying online, please don't hesitate to email us at [e-mail] . We're here to help.

About Imperial

Welcome to Imperial, a global top-ten university where scientific imagination leads to world-changing impact.

Join us and be part of something bigger. From global health to climate change, AI to business leadership, here at Imperial we navigate some of the world’s toughest challenges. Whatever your role, your contribution will have a lasting impact.

As a member of our vibrant community of 22,000 students and 8,000 staff, you’ll collaborate with passionate minds across nine London campuses and a global network.

This is your chance to help shape the future. We hope you’ll join us at Imperial College London.

Our Culture

We work towards equality of opportunity, to eliminating discrimination, and to creating an inclusive working environment for all. We encourage applications from all backgrounds, communities and industries, and are committed to employing a team that has diverse skills, experiences and abilities. You can read more about our commitment on our web pages .

Proud signatory of the Armed Forces Covenant. We welcome applications from the Armed Forces community.

Our values are at the root of everything we do, and everyone in our community is expected to demonstrate respect, collaboration, excellence, integrity, and innovation.