Senior Clinical Research Fellow in Diabetes and Endocrinology

Job summary
We are looking for an individual with appropriate skills to support research activities of the department. This is an excellent opportunity to join a first-class team in an active and progressive central London teaching hospital environment. The post offers an exciting and unique opportunity to gain research experience in diverse aspects of diabetes and endocrine trials. The post holder will be responsible for supporting clinical trials in Diabetes, Obesity and other endocrine conditions within the department.

It is envisaged that the fellow will acquire a variety of clinical skills, including service development and research experience through various projects. Guys and St Thomas NHS Foundation Trust and King's College London also have access to research courses, training and collaborative links to ensure the fellow can obtain competencies and receive support in key areas for their projects and/or future development.

Main duties of the job
The post holder supports and coordinates the GCP compliant setup, delivery and close down of a portfolio of research studies across the Diabetes and Endocrine department, ensuring teams are supported to setup and deliver studies in a timely manner by providing appropriate medical oversight of the portfolio. The research fellow will facilitate and aid recruitment of participants. The role will include identifying, consenting and following up suitable patients for clinical research, working autonomously within professional practice guidelines and within the Research Governance Framework.

The post holder will take responsibility for the safe administration of experimental therapies, and for monitoring the expected and unexpected side effects of drugs and other treatment modalities used in these trials. They will have duty of care in supporting research participants and their families throughout their participation in any research activity. They will also act as a patient advocate providing support and oversight as required.

In conjunction with the other members of the team, they will facilitate the production of good quality of research.

About us
The Department of Diabetes and Endocrinology is part of the Clinical Directorate of Specialist Ambulatory and Medical Services. The Diabetes and Endocrinology Department is an important element of local and tertiary medical services. It is principally an outpatient speciality and treats approximately 20,000 patients each year including many tertiary referrals for diabetes, lipid, obesity, metabolic and endocrine disorders. The clinics are accommodated in modern purpose-built Day Centres on both the Guy's and St. Thomas' sites. The Diabetes service also provides community-based clinics. The department is currently involved in many exciting initiatives including supporting the establishment of Tier 3 and Tier 4 structured weight loss services across South London. As a tertiary centre for type 1 diabetes with a large patient cohort, we support the use of diabetes technologies such as insulin pumps, CGM and hybrid closed loop systems. We are supported by a skilled multidisciplinary team of doctors, specialist nurses, dieticians, psychologists and psychiatrists and pump coordinators. We also have a growing Diabetes Oncology service linked to the Guy's Cancer centre, which supporting patients currently receiving cancer care complicated by hyperglycaemia, secondary to steroids and cancer treatments.

Key duties/responsibilities

• The Clinical Research Fellow will be responsible for delivering clinical research projects under the supervision of the Principal Investigator.
• Full training in relevant clinical research skills including clinical trial conduct will be provided.
• Duties will include, but are not limited to:
  • Screening and recruitment of potentially eligible patients
  • Consent and enrolment of participants.
  • Support, follow-up and clinical assessments of enrolled study participants and families according to the study protocol.
  • Liaison with R&D and collaborators.
  • Maintaining productive working relationships with the Diabetes and Endocrine research delivery team.
  • Collection and quantitative/qualitative analysis of study data and maintenance of database.
  • Preparation of study documents, ethics applications, study materials and reports.
  • Presentation and dissemination of progress/findings via multiple media including manuscript publication.
  • Clinical trial management and conduct according to GCP principles
  • Teaching and training of medical, nursing and allied staff as well as medical students.
• There are no on-call duties attributable to this research post. The post holder will be expected to work 40 hours a week on average, principally within normal weekday hours but allowing a degree of flexibility to suit the needs of the proposed research. The principal site of work will be Guys Hospital, although the post holder may also be required to work at the St Thomas site and in the community.

Other responsibilities
Clinical:
The post holder will, together with colleagues, be responsible for the provision of services to the Guys & St Thomas NHS Foundation Trust to include:
(a) Diagnosis and treatment of patients of the trust in such hospitals, health centres or clinics or other premises as required.
(b) Continuing clinical responsibility for the patients in your charge, allowing for all proper delegation to, and training of, your staff.

Clinical and Communication Responsibilities

• Manage a caseload of participants acting as a professional in ensuring a duty of care to the participant and their families.
• Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice), Trusts policies, research governance, Medicines for Human Use (Clinical Trials Regulations) Regulations, Data Protection Act and Human Tissue Act.
• Ensuring that the clinical trial protocol is adhered to at all times.
• Devise, implement and evaluate strategies for identifying eligible participants for research studies, including by attending clinics, departments, screening notes/consultant referral and Multidisciplinary Team (MDT) meetings.
• Take informed consent and ensure on-going consent in accordance with the necessary Trust research governance arrangements and necessary competent regulatory authority Regulations and International Conference on Harmonisation of Good Clinical Practice (ICH GCP)
• Coordinate the research participant pathway from screening through to study closure.
• Set up, collect and maintain adequate trial data and documentation via completion of participant records/case reports forms and investigator site files, ensuring the necessary information is documented in the electronic medical notes and databases, and communicated with clinical teams.
• Report any adverse events or health concerns which occur whilst the participant is taking part in the study to the appropriate doctor in a timely manner.
• Undertake a range of clinical tasks in line with personal, professional competencies and as stipulated in approved study protocols such as blood pressure, temperature, respiration, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
• Perform tasks requiring clinical and laboratory skills, including drug administration and clinical observation, phlebotomy, venepuncture, biological sample preparation within clinical area and laboratories as stipulated in approved protocols and laboratory manuals as required.
• Have responsibility for the correct administration and custody of medicines according to Trust policy.
• Liaise with the clinical team to organise and ensure that study specific investigations are undertaken according to the protocol, obtain and document the results.
• Report any side effects or adverse events according to protocol guidelines and within the required time frame.
• Deal with concerns raised by participants and visitors in a proactive manner and take remedial action as necessary.
• Report to the senior clinical research staff and the principal investigator any clinical incidences. Assist in managing incidents, accidents and complaints in accordance with Trust Policies.
• Manage clinical incidents effectively.
• Carry out planned care required by the clinical trials protocol for participants and patients without direct supervision
• Act as a patient advocate enabling patients to make informed choices concerning their involvement in the clinical trials and ensuring advice and information is provided.
• Deal with concerns raised in a proactive manner and take remedial action as necessary.

*** Please be advised that this vacancy may close early should we receive sufficient number of applications ***

Person Specification
Qualifications and Training

• Full GMC Registration and hold a licence to practise
• Evidence of continuous professional development
• Good Clinical Practice certificate

Desirable

• Specialty qualification, and/or higher degree (Diabetes and Endocrine)
• MRCP (part 1) or equivalent

Clinical Experience

• 4 complete postgraduate years, or equivalent
• Comprehensive clinical experience in management of Diabetes and Endocrine conditions
• Experience in the assessment and management of patients for obesity and its complications
• Prior experience of independently managing research participants in Diabetes and Endocrine settings

Desirable

• Experience in Diabetes technology
• Experience in prescription and management of GLP-1

Knowledge and Skills

• Ability to work as an effective member of a multidisciplinary team
• Excellent interpersonal skills, including confident and comfortable interaction with trial participants, clinical and research team members, and the broader research community

Desirable

• Fluent use of IT including email, word processing, spreadsheet, database Expertise in statistics and data analysis
• Expertise in statistics and data analysis
• Previous use of research database

Research

• Understanding of the principles and applications of clinical research
• Evidence of previous experience delivering research activities involving human subjects

Desirable

• Evidence of original research
• Evidence of presentations, posters and publications

Teaching

• Experience of undergraduate teaching and post graduate training

Desirable

• Teaching qualification

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applicants must have current UK professional registration. For further information please see NHS Careers website.