Research Regulatory Facilitator

About the role

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/ICHTAct 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/ICHTTo 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…