Job summary
Imperial College Healthcare NHS Trust at St Mary's Hospital is working with a commercial contract research organisation (CRO) to conduct a double-blind placebo-controlled Phase 2a clinical trial in chronic obstructive pulmonary disease (COPD) using a novel rhinovirus challenge model. The success of this Phase 2a trial will not only provide novel treatment alternatives for COPD exacerbations but will offer the opportunity for publications in high impact journals such as the New England Journal of Medicine. We are looking to employ a full- time clinical research fellow for 1 year initially (up to SP2 level) who will be employed via Imperial College Healthcare NHS Trust based at St Mary's Hospital to act as lead physician and be responsible for running the trial. The postholder will be supported by Imperial College London professors, chief investigators, research nurses and also CRO staff to recruit study subjects in a timely manner. The position is highly suited to a clinical fellow interested in a career in respiratory medicine with aspirations to gain experience working with industry or pursue a career in academia.
Main duties of the job
This is a 100% clinical research post. Main duties will include to support the timely delivery of a Phase 2a clinical trial, in-line with the requirements of sponsors, GCP, GDPR, and other appropriate guidelines and regulations; be responsible for participant recruitment and overseeing participant clinical study visits; be responsible for specific study-related medical decisions as agreed with the Study Chief Investigator; evaluate and manage any acute, sub-acute and chronic adverse drug reactions under the supervision of the Chief Investigator and/or Medical Monitor; assess and interpret safety and clinical data from assigned studies, e.g. vital signs, ECG's, laboratory tests, lung function tests adverse events etc; maintain accurate and accessible research records and medical notes; attend regular conference calls with sponsor, CRO staff of study team. There will be some after hours or weekend work in line with participant clinical visits as outlined in the study protocol.
About us
At Imperial College Healthcare you can achieve extraordinary things with extraordinary people, working with leading clinicians pushing boundaries in patient care. Become part of a vibrant team living our values - expert, kind, collaborative and aspirational. You'll get an experience like no other and will fast forward your career. Benefits include career development, flexible working and wellbeing, staff recognition scheme. Make use of optional benefits including Cycle to work, car lease schemes, season ticket loan or membership options for onsite leisure facilities.
We encourage staff to have the Covid vaccination to protect themselves, patients, other colleagues as well as the wider community. Please note it is an operational requirement to comply with infection prevention and control procedures within the Trust such as lateral flow testing, handwashing and the wearing of masks, according to the procedures in place at any time or location.
As part of our continued response to Covid19 we are still conducting the majority of our interviews virtually.
We are committed to equal opportunities and improving the working lives of our staff and will consider applications to work flexibly, part-time or job share. Please talk to us at interview.
Job description
Job responsibilities
Patient/Client Care:
- Support the timely delivery of clinical studies, in-line with the requirements of sponsors, trial co-ordinators, GCP, GDPR, and other appropriate guidelines and regulations;
- Provide medical assessment and cover for selected research studies in the ICRRU portfolio working alongside other clinical teams if required;
- Accept delegated responsibility to ensure that assigned studies in ICRRU are carried out safely and in compliance with the protocol;
- Be responsible for specific study-related medical decisions as agreed with the Study Chief Investigator;
- Perform clinical procedures as appropriate to the assigned study (including, but not limited to, clinical examinations or testing, dispensing innovative new medicines, assessment of adverse events and management of any severe adverse events);
- Ensure that patients/participants in assigned studies give fully informed consent in writing before commencing a study;
- Assess the eligibility status of any referrals for experimental treatments, maintain and update a screening list;
- Evaluate and manage any acute, sub-acute and chronic adverse drug reactions under the supervision of the Chief Investigator and/or Medical Monitor;
- Assess and interpret safety and clinical data from assigned studies, e.g. vital signs, ECG's, laboratory tests, lung function tests etc;
- Follow up and report adverse events as necessary. Communicate safety issues to the Chief Investigator for a study, report Serious Adverse Events in accordance with the protocol and Good Clinical Practice;
- Review study documentation and complete appropriate sections of Case Report Forms (CRF);
- Ensure that all clinical activities within the CRF are conducted in accordance with approved Standard Operating Procedures (SOPs);
- Maintain accurate and accessible research records and medical notes
Management:
- Provide medical input into integrated clinical, safety and statistical reports as requested;
- Provide medical input and review of study protocol amendments and other related study documentation and participate in research meetings, conference calls, study review meetings and meetings with chief investigators, clinical trial co-ordinators, trial monitors and study sponsors;
- 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;
- Develop and maintain computer skills to utilise available systems for the efficient management and administration of the day to day activities of the ICRRU team
- Any other duties as may be deemed reasonable by senior clinical staff of ICRU
Education & Training:
- To participate in training of other study team members such as research nurses if required
Job description
Job responsibilities
Patient/Client Care:
- Support the timely delivery of clinical studies, in-line with the requirements of sponsors, trial co-ordinators, GCP, GDPR, and other appropriate guidelines and regulations;
- Provide medical assessment and cover for selected research studies in the ICRRU portfolio working alongside other clinical teams if required;
- Accept delegated responsibility to ensure that assigned studies in ICRRU are carried out safely and in compliance with the protocol;
- Be responsible for specific study-related medical decisions as agreed with the Study Chief Investigator;
- Perform clinical procedures as appropriate to the assigned study (including, but not limited to, clinical examinations or testing, dispensing innovative new medicines, assessment of adverse events and management of any severe adverse events);
- Ensure that patients/participants in assigned studies give fully informed consent in writing before commencing a study;
- Assess the eligibility status of any referrals for experimental treatments, maintain and update a screening list;
- Evaluate and manage any acute, sub-acute and chronic adverse drug reactions under the supervision of the Chief Investigator and/or Medical Monitor;
- Assess and interpret safety and clinical data from assigned studies, e.g. vital signs, ECG's, laboratory tests, lung function tests etc;
- Follow up and report adverse events as necessary. Communicate safety issues to the Chief Investigator for a study, report Serious Adverse Events in accordance with the protocol and Good Clinical Practice;
- Review study documentation and complete appropriate sections of Case Report Forms (CRF);
- Ensure that all clinical activities within the CRF are conducted in accordance with approved Standard Operating Procedures (SOPs);
- Maintain accurate and accessible research records and medical notes
Management:
- Provide medical input into integrated clinical, safety and statistical reports as requested;
- Provide medical input and review of study protocol amendments and other related study documentation and participate in research meetings, conference calls, study review meetings and meetings with chief investigators, clinical trial co-ordinators, trial monitors and study sponsors;
- 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;
- Develop and maintain computer skills to utilise available systems for the efficient management and administration of the day to day activities of the ICRRU team
- Any other duties as may be deemed reasonable by senior clinical staff of ICRU
Education & Training:
- To participate in training of other study team members such as research nurses if required
Person Specification
Qualifications
Essential
- MBBS or equivalent with full valid GMC Registration and hold a licence to practise
- Postgraduate specialist qualification e.g. MRCP or equivalent
Desirable
Experience
Essential
- Experience in respiratory medicine; inclusive of COPD
Desirable
- Familiarity with principles of clinical research
- An interest in virology and host responses to virus infections
Clinical skills
Essential
- oPhysical examination
- oECG, chest X ray, other radiology interpretation, biochemistry, haematology results interpretation
- oVenepuncture, IV lines
- oAbility to learn and implement new study related clinical skills
Desirable
- Experience of lung function assessments
- Experience with induced sputum collection
Communication skills
Essential
- Excellent written communication skills
- Excellent interpersonal, verbal, communication skills
Person Specification
Qualifications
Essential
- MBBS or equivalent with full valid GMC Registration and hold a licence to practise
- Postgraduate specialist qualification e.g. MRCP or equivalent
Desirable
Experience
Essential
- Experience in respiratory medicine; inclusive of COPD
Desirable
- Familiarity with principles of clinical research
- An interest in virology and host responses to virus infections
Clinical skills
Essential
- oPhysical examination
- oECG, chest X ray, other radiology interpretation, biochemistry, haematology results interpretation
- oVenepuncture, IV lines
- oAbility to learn and implement new study related clinical skills
Desirable
- Experience of lung function assessments
- Experience with induced sputum collection
Communication skills
Essential
- Excellent written communication skills
- Excellent interpersonal, verbal, communication skills
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
