Job summary
GUY'S AND ST. THOMAS' HOSPITAL NHS FOUNDATION TRUST
Clinical Research Facility (CRF) Junior Research Physician
Nodal Point - 4
Full Time - 40 hrs
Fixed Term - 18 months
The NIHR Clinical Research Facility (CRF) at Guy's and St. Thomas' NHS Foundation Trust is looking to appoint a new CRF Junior Research Physician. This is an excellent opportunity for a doctor with recent experience in acute medicine to gain experience of clinical research, including world-leading early phase trials, across a broad range of medical specialities within the supportive environment of a leading teaching and research hospital. The position provides the post holder with the opportunity to be involved in the testing of treatments and interventions that could shape the healthcare of tomorrow.
Main duties of the job
The post holder will work alongside experienced Principal Investigators (PI) within a multidisciplinary team. The post holder will provide medical support for patients and healthy volunteers participating in the clinical trials running in our units.
The CRF incorporates our MHRA accredited Phase I unit. Supporting the activity of the Phase I unit is a core component of the Junior CRF Research Physician role providing the post holder the opportunity to work with novel and advanced therapies prior to market authorisation. As part of this work, the post holder will support risk assessments, developing and implementing critical risk mitigation strategies for new early phase studies; this will include trials employing advanced therapies under the oversight of first-in-human accredited investigators.
The post holder will work collaboratively with our management team to shape and guide the service as we expand the scope and breadth of the service. The post holder will be actively encouraged to contribute to the work of the UK Clinical Research Network (UKCRF) working groups and present relevant outcomes at national conferences.
The post would suit doctors aiming for a career in Clinical Pharmacology, Translational Medicine or Pharmaceutical medicine. It may also suit a General Practitioner looking to explore new career opportunities or a junior doctor looking for an engaging and informative rotation in clinical research.
About us
As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends.
Our excellent benefits include final salary pension scheme. Please visit our website to find out more.
Equality of opportunity is our Policy. The Trust provides health services to a diverse community.
Please note that successful completion of the International English Language Testing System (IELTS) is our accepted minimum language requirement.
Job description
Job responsibilities
Duties and Responsibilities:As the CRF Junior Research Physician, the post holder will: Support the timely delivery of clinical studies to acceptable medical standards, in-line with the requirements of sponsors, ICH GCP, and other appropriate guidelines and regulations. Provide medical assessment and cover for selected studies in the CRF working alongside the CRFs senior clinical team and nurse in charge for the day; In partnership with the CRF Directors and staff, initiate definitive strategies to anticipate and expertly manage medical safety issues, including emergencies; Support aspects of subject recruitment, including pre-study medical histories, informed consent, medical examinations for ongoing studies, dosing of study medication; Where required, provide medical cover outside of normal working hours, as determined by the nature of the studies being undertaken in the CRF at the time; Accept delegated responsibility to ensure that assigned studies in the CRF are carried out safely and in compliance with the protocol; Be responsible for specific study-related medical decisions as agreed with the Study Principal Investigator; Perform clinical procedures as appropriate to the assigned study (including, but not limited to, clinical examinations or testing, insertion of intravenous lines, assessment of adverse events and management of medical emergencies); Ensure that patients/volunteers in assigned studies give fully informed consent in writing before commencing a study; Assess the eligibility status of referrals for experimental treatments, maintain and update a screening list. Evaluate and manage acute, sub-acute and chronic adverse drug reactions and manage acute toxicological emergencies under the supervision of the consultants in charge. Assess and interpret safety and clinical data from assigned studies, e.g. Vital signs, ECG's, laboratory tests, adverse events etc; Follow up and report adverse events as necessary. Communicate safety issues to the Principal Investigator for a study, the Head of Department or Designee, report Serious Adverse Events to the study sponsor in accordance with Good Clinical Practice; Review study documentation and complete appropriate sections of Case Report Forms; Ensure that all clinical activities within the CRF are conducted in accordance with approved Standard Operating Procedures (SOPs) Participate in the writing, and review, of appropriate CRF SOPs in association with senior medical colleagues and the BRC and CRF Quality Team; Maintain accurate and accessible research records and medical notes; Provide medical input into integrated clinical, safety and statistical reports as requested; Contribute to the risk assessment and planning of risk mitigation strategies for early phase trials;
Provide medical input and review of study protocols and other related study documentation and participate in research meetings, study review meetings, and meetings with principal investigators and study sponsors; Maintain awareness and keep abreast of latest technologies in the medical field and share that knowledge with the Quintiles Drug Research Unit clinical team and CRF team; Prepare reports for submission to pharmaceutical companies, regulatory bodies, and medical and scientific journals as appropriate; Ensure personal Trust mandatory training is up to date and support the training of medical, nursing and ancillary staff as required; Assist with business development activities as appropriate including the development and maintenance of professional relationships with local opinion leaders and other GSTT/KCL departments; Develop and maintain computer skills to utilise available systems for the efficient management and administration of the day to day activities of the CRF; Any other duties as may be deemed reasonable by the CRF Directors. To participate in clinical and other service activities with the object of ensuring a high standard of patient care To participate in undergraduate and postgraduate teaching and training
Job description
Job responsibilities
Duties and Responsibilities:As the CRF Junior Research Physician, the post holder will: Support the timely delivery of clinical studies to acceptable medical standards, in-line with the requirements of sponsors, ICH GCP, and other appropriate guidelines and regulations. Provide medical assessment and cover for selected studies in the CRF working alongside the CRFs senior clinical team and nurse in charge for the day; In partnership with the CRF Directors and staff, initiate definitive strategies to anticipate and expertly manage medical safety issues, including emergencies; Support aspects of subject recruitment, including pre-study medical histories, informed consent, medical examinations for ongoing studies, dosing of study medication; Where required, provide medical cover outside of normal working hours, as determined by the nature of the studies being undertaken in the CRF at the time; Accept delegated responsibility to ensure that assigned studies in the CRF are carried out safely and in compliance with the protocol; Be responsible for specific study-related medical decisions as agreed with the Study Principal Investigator; Perform clinical procedures as appropriate to the assigned study (including, but not limited to, clinical examinations or testing, insertion of intravenous lines, assessment of adverse events and management of medical emergencies); Ensure that patients/volunteers in assigned studies give fully informed consent in writing before commencing a study; Assess the eligibility status of referrals for experimental treatments, maintain and update a screening list. Evaluate and manage acute, sub-acute and chronic adverse drug reactions and manage acute toxicological emergencies under the supervision of the consultants in charge. Assess and interpret safety and clinical data from assigned studies, e.g. Vital signs, ECG's, laboratory tests, adverse events etc; Follow up and report adverse events as necessary. Communicate safety issues to the Principal Investigator for a study, the Head of Department or Designee, report Serious Adverse Events to the study sponsor in accordance with Good Clinical Practice; Review study documentation and complete appropriate sections of Case Report Forms; Ensure that all clinical activities within the CRF are conducted in accordance with approved Standard Operating Procedures (SOPs) Participate in the writing, and review, of appropriate CRF SOPs in association with senior medical colleagues and the BRC and CRF Quality Team; Maintain accurate and accessible research records and medical notes; Provide medical input into integrated clinical, safety and statistical reports as requested; Contribute to the risk assessment and planning of risk mitigation strategies for early phase trials;
Provide medical input and review of study protocols and other related study documentation and participate in research meetings, study review meetings, and meetings with principal investigators and study sponsors; Maintain awareness and keep abreast of latest technologies in the medical field and share that knowledge with the Quintiles Drug Research Unit clinical team and CRF team; Prepare reports for submission to pharmaceutical companies, regulatory bodies, and medical and scientific journals as appropriate; Ensure personal Trust mandatory training is up to date and support the training of medical, nursing and ancillary staff as required; Assist with business development activities as appropriate including the development and maintenance of professional relationships with local opinion leaders and other GSTT/KCL departments; Develop and maintain computer skills to utilise available systems for the efficient management and administration of the day to day activities of the CRF; Any other duties as may be deemed reasonable by the CRF Directors. To participate in clinical and other service activities with the object of ensuring a high standard of patient care To participate in undergraduate and postgraduate teaching and training
Person Specification
Qualifications and Training
Essential
- MBBS or equivalent with full valid GMC Registration and hold a licence to practise
- Recent ALS training allowing direct medical responsibility for human investigations in the UK
Desirable
- Postgraduate specialist qualification eg MRCP or equivalent.
Clinical Experience
Essential
- A minimum of 2 years post-registration experience.
- Experience of supervising / training others.
Desirable
- Experience in the conduct of clinical pharmacology studies.
Knowledge and Skills
Essential
- Ability to work as an effective member of a multidisciplinary team.
- Excellent interpersonal, verbal, and written communication skills.
- Experienced in the use MS Word, Excel, PowerPoint.
- Ability to discuss and appropriately escalate to the consultant(s) in charge the medical needs of patients referred to the CRF.
- Ability to learn and implement new study related clinical skills (including but not limited to skin and abdominal fat biopsies, VO2 max exercise testing, etc.).
Desirable
- Familiarity with principles of clinical research, including Good Clinical Practice, pharmacokinetics, human toxicology, statistics and pharmacodynamic assessment.
- Basic knowledge of statistics.
- Competence in venous cannulation.
Research
Essential
- Understanding of the principles and applications of clinical research.
- Good understanding and experience of the regulatory environment for clinical trials and clinical research in the UK.
Desirable
- Evidence of original research.
Management
Essential
- Evidence of understanding of the role of clinical management.
Desirable
- Management training or qualification.
- Evidence of leadership in the development of clinical services.
Other
Essential
- Evidence of understanding of and adherence to the principles of Good Medical Practice set out by the General Medical Council.
- Evidence of contribution to effective clinical audit and clinical risk management.
- Ability to exercise initiative and work independently.
Desirable
- Experience in clinical guideline development.
- Appraisal training.
Person Specification
Qualifications and Training
Essential
- MBBS or equivalent with full valid GMC Registration and hold a licence to practise
- Recent ALS training allowing direct medical responsibility for human investigations in the UK
Desirable
- Postgraduate specialist qualification eg MRCP or equivalent.
Clinical Experience
Essential
- A minimum of 2 years post-registration experience.
- Experience of supervising / training others.
Desirable
- Experience in the conduct of clinical pharmacology studies.
Knowledge and Skills
Essential
- Ability to work as an effective member of a multidisciplinary team.
- Excellent interpersonal, verbal, and written communication skills.
- Experienced in the use MS Word, Excel, PowerPoint.
- Ability to discuss and appropriately escalate to the consultant(s) in charge the medical needs of patients referred to the CRF.
- Ability to learn and implement new study related clinical skills (including but not limited to skin and abdominal fat biopsies, VO2 max exercise testing, etc.).
Desirable
- Familiarity with principles of clinical research, including Good Clinical Practice, pharmacokinetics, human toxicology, statistics and pharmacodynamic assessment.
- Basic knowledge of statistics.
- Competence in venous cannulation.
Research
Essential
- Understanding of the principles and applications of clinical research.
- Good understanding and experience of the regulatory environment for clinical trials and clinical research in the UK.
Desirable
- Evidence of original research.
Management
Essential
- Evidence of understanding of the role of clinical management.
Desirable
- Management training or qualification.
- Evidence of leadership in the development of clinical services.
Other
Essential
- Evidence of understanding of and adherence to the principles of Good Medical Practice set out by the General Medical Council.
- Evidence of contribution to effective clinical audit and clinical risk management.
- Ability to exercise initiative and work independently.
Desirable
- Experience in clinical guideline development.
- Appraisal training.
Disclosure and Barring Service Check
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Disclosure and Barring Service Check
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
