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Job Opportunity for Clinical Research Associate
Translational and Clinical Research Institute Faculty of Medical Sciences, Newcastle University
Autologous Tolerogenic Dendritic cells for Rheumatoid Arthritis (AuToDeCRA) is our flagship programme investigating the potential of a cellular therapy, derived from a rheumatoid arthritis patient’s own peripheral blood, to intercept the disease process. We are now preparing for our second human trial of this therapy, AuToDeCRA-2. This study will compare different routes of administration, using immune monitoring to track the impact of this novel cellular therapy over a period of three months. It may also be possible to track the injected cells using MRI. This role is funded by an IMI2 project, Rheumatherapy Cure (RTcure), and linked to a Versus Arthritis project, Autologous Tolerogenic Dendritic Cells for Rheumatoid Arthritis-2 (AuToDeCRA-2). RTcure is studying methods to prevent or cure autoimmune rheumatic diseases, particularly rheumatoid arthritis (RA), with a particular emphasis on biomarkers.
This post provides a unique opportunity for an ambitious clinician to develop a practical understanding of experimental medicine research. The Clinical Research Associate (CRA) will be responsible for delivering AuToDeCRA-2. They will play a central role in the AuToDeCRA-2 team, acting as a liaison between the research laboratory team, the Good Manufacturing Practice (GMP) advanced therapies laboratory, the NHS rheumatology team and the NIHR Clinical Research Facility. The postholder will be responsible for identifying potential participants, via face-to-face and telephone consultations, explaining the study to them, and obtaining consent. They will also be responsible for overall trial management and logistics, including oversight of study visits, preparing study reports and manuscripts. We have a well-staffed laboratory infrastructure and there may also be the possibility to develop laboratory skills, dependent on further funding.
You are a dynamic, conscientious, self-motivated team player, with a thirst for new knowledge and an appetite for discovery. This post is funded for two years but will provide an excellent platform for a research fellowship, potentially leading to a higher degree. You will work closely with various members of the Musculoskeletal Research Group, particularly Professor J Isaacs and Dr A Pratt, to whom informal enquiries can be made: firstname.lastname@example.org, Arthur.email@example.com
Candidates should attach a statement to their application that describes their research interests and, in particular, highlights their relevant experience.
Deadline: 31st July 2021
For more information and to apply, visit:
Main Dutues and Responsibilities
- Familiarise oneself with study protocol and all other relevant study documentation.
- Develop a logistical framework for participants, to enable efficient participation – in particular arranging for imaging investigations if relevant, and liaison between the advanced therapies facility, musculoskeletal research laboratories, clinical research facility and trial team.
- Learn to perform intradermal injections (if not already skilled in this procedure).
- Develop a standard operating procedure for handling of research blood samples after acquisition.
- Identify suitable participants for AuToDeCRA-2 and, where appropriate, obtain informed consent.
- Oversee study participation, including cell injection.
- Ensure that, once collected, research samples are processed and stored appropriately, according to the standard operating procedure.
- Alongside other AuToDeCRA-2 investigators, devise an appropriate data analysis plan for the study.
- Develop study reports and prepare data for publication in relevant, high impact factor journals.
- Provide guidance to other staff and students, potentially including supervision of undergraduate research project students.
- Attend and present your work at laboratory, and national/international meetings.
- Be prepared to contribute to events celebrating the public engagement of science/social sciences/humanities.
- Contribution to the research programme of the Translational and Clinical Research Institute under the clear guidance of a member of an academic staff or Principal Investigator.
- Co-ordinate own work with that of others, deal with problems which may affect the achievement of research objectives and contribute to the planning of the project
- Present information on research progress and outcomes to the Principal Investigator or groups overseeing the research project
- Write up results from own research activity and provide input into the research project’s dissemination, in whatever form (report, papers, chapters)
- Work to deadlines and manage, with support, competing priorities
- Ensure that personal knowledge and training in relevant fields of study is kept up to date
- Closely managed by a senior academic or Principal Investigator
- May work with other researchers in a team and actively participate in collaborative research
- Liaise with research colleagues and support staff on day-to-day issues
- May provide guidance as required to any support staff and/or research students
- May in some parts of the University work alongside, and help informally, students working in the same laboratory
- May be involved in the recruitment and delivery of other related clinical trials and support the specialist clinical rheumatology services.
Knowledge, Skills and Experience
- Considerable subject knowledge in rheumatology and autoimmune rheumatic disease
- The ability to work flexibly according to study needs
- The ability to work collaboratively with colleagues
- Good level of analytical skills and the ability to communicate complex information clearly, both orally and through the written word.
- The ability to use personal initiative and creativity to solve research problems
- Ability to extract and interpret complex medical information from medical records
- Interpersonal skills to communicate effectively with patients and families
- Excellent planning and organisation skills and ability to prioritise competing demands
- Excellent record keeping
- Demonstrable clinical research experience in rheumatology and autoimmune rheumatic disease, particularly rheumatoid arthritis
- Training in GCP and taking informed consent
- Evidence of academic aptitude (e.g. publications/presentations)
- Experience of using electronic patient records
- Experience in the recruitment, conduct and care of patients participating in experimental medicine studies
Attributes and Behaviour
- Able to work as part of a team but also independently
- Able to collect, organise and analyse complex datasets
- Enthusiastic and curious
- Ability to work flexibly, and under pressure
- Good interpersonal skills; able to effectively work with others, including colleagues, other staff, patients and their families
- Degree in medicine
- GMC registration
- MRCP part 1 UK or equivalent