Respiratory Physician : clinical trial support

Reporting to Dr Michael R Edwards (Managing & Scientific Director) & Professor Sebastian L Johnston (Chairman & Chief Medical Officer). The position is a full time or part-time/flexible position responsible for performing clinical trial support as a respiratory physician for Virtus Respiratory Research Limited. We require a clinical research fellow (up to ST3 level) to act as study physician on commercial clinical trials on participants with asthma and chronic obstructive pulmonary disease (COPD). The post holder will work with experienced academics with the Imperial Clinical Respiratory Research Unit (ICRRU) within the NHS and a commercial contract research organization that will manage the trial.

The postholder will be responsible for recruiting and screening trial participants and conducting on-site clinical assessments as per trial protocols. The position would ideally suit someone who has worked within the NHS supporting clinical trials or other research projects and wants a future career in industry.

Key responsibilities & accountabilities:

• Support the timely delivery of clinical studies, in-line with the requirements of sponsors, trial co-ordinators, according to 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;
• Provide medical input on additional draft trial protocols, eCRFs or other trial documentation as required.

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 ICRRU.

Please note the above position will require occasional after hours or weekend work.

Education & Training:

To participate in training of other study team members such as research nurses if required.