Research Support and Business Functions

Organisation which host or sponsor clinical research are supported by a range of skilled professional teams. These teams ensure studies are well delivered and run in accordance with requirements.

Teams:

• conduct regulatory checks,
• manage research operations,
• assess study finances,
• manage and oversee research budgets,
• review agreements and contracts,
• provide study sponsorship or approved to start,
• assure quality, safety, and data integrity within studies.

These teams will also lead activities to grow, promote and improve research practices such as supporting patient and public involvement, reporting on research performance, and developing strategies and policies. Some teams are supported by dedicated research communications teams.

These teams will often work together within a single department which is commonly known as a Research and Development (R&D) or Research and Innovation Department. Some large NHS/University partnerships may have larger R&D departments which work across both organisations and often known as Joint Research Offices/departments.

R&D offices are made up of multi-disciplinary teams/individuals drawn from different professional groups e.g., finance, contracting, regulatory and administrative. Entry to each type of career depends upon the size and complexity of the organisations research. Some R&D functions offer on-the-job training which means that entrants can be drawn from other, comparable professionals and/or graduates and school leavers (depending on the type of role).

Find out more about some of the functions of R&D offices - including the types of jobs and insights from current professionals - by following the links at the end of this page.

Further information about research and development functions can be found at:

• UCLH/UCL Joint Research Office
• NHS R&D Forum
• The Health Research Authority
• UK Policy Framework for Health and Social Care

The following links are useful for those looking to build relevant knowledge and training in areas relevant to research and development careers:

• UCLH/UCL Joint Research Office training, including GCP and PPI
• North Thames Clinical Research Network Training including GCP, PPI SOECAT (costings) and research fundamentals
• UCL Institute of Clinical Trials and Methodology
• NIHR learning portal
• NHS R&D Forum courses and symposia

Research Finance and Contracting

Research finance within R&D offices are often divided costing and financial management. Costing functions will review the cost of running a research study and will advise on budgets and funding sources. Costing professionals in the NHS work within the requirements of ACCORD and use tools such as SOECAT. Financial management involves management of departmental or group budgets and reporting on income and spend.

Professionals working in research finance usually have experience in finance related roles in comparable sectors.

Research contracting within R&D offices review and negotiate contracts which are required for studies. These may include contracts between sites, sites and sponsors and sites/sponsors and third parties. The range of contracts can also include material and data transfers, confidentiality and collaboration agreements.

Professionals working in research contracting usually have experience in managing agreements or contracts within research or other legal sectors.  On the job training means that some junior roles are open to graduates.

Studies require sponsorship by an organisation. In many cases, the organisation is an NHS trust or an academic institution (e.g., university). Where a research study is undertaken within an NHS or social care site (e.g., a hospital), an additional site approval is required. R&D offices conduct and issue both sponsorship and site (or host) approvals. Both approvals follow a set of national and local checks and requirements. Research officers or coordinators work in R&D offices to conduct and coordinate these checks and issue these approvals. Some organisations have complex research portfolio’s which require the support of additional specialist support staff such as research pharmacists, pharmacovigilance managers, statisticians, and data management.

Information on sponsorship and host approvals at UCLH and UCL can be found on the JRO website.

Professionals working in research governance are drawn from a variety of backgrounds. Experience in research governance or assurance is often required for roles related to sponsorship. On-the-job training means governance (host) roles are also available to graduates and school leavers and from other NHS or academic professions such as operations, administration, project management/coordination. Research Regulations and Governance offers opportunity to motivated individual to progress from entry level bands to management and leadership roles within R&D offices, research teams, commercial sector, regulators and research government bodies.

Research Data and Information

R&D Offices host the organisations database of clinical research studies. These central databases will include key information about each study approved within the organisation. R&D data administration and management teams will develop and maintain these databases. These team can also input or oversee entries to other related databases. Other databases maybe hosted elsewhere within an organisation or held in national databases managed by the NIHR or Department of Health. Data teams also provide reports on performance including delivery against expected milestones and targets and other KPIs. Some data teams also take responsibility for archiving and record management for R&D offices.