The primary responsibility of a Clinical Research Physician is to provide medical support for human volunteer studies of new and existing pharmaceuticals performed in an Early Phase Clinical Unit (EPCU).
Key Accountabilities and Supporting Activities
To perform the duties of Clinical Investigator during clinical trials according to International Conference on Harmonisation (ICH) Good Clinical Practice and to the highest standard to ensure that the welfare of the subjects and the quality and credibility of study data is maintained
To provide medical support for clinical studies of new and existing pharmaceuticals performed in the Early Phase Clinical Unit (EPCU) – London
To perform pre-study medical histories and medical examinations for studies performed in the EPCU London and to decide on a Volunteer’s suitability for inclusion in a study and for joining the EPCU volunteer panel
To ensure that volunteers give fully informed consent in writing before commencing a study
To assess and interpret study clinical data, e.g. Heart rates, BP, ECG’s, laboratory tests, adverse events etc.
To provide medical cover outside of normal working hours for the EPCU as part of an on call rota
To be proficient in procedures of ALS and to be capable of dealing with acute medical emergencies arising in the Unit
To be responsible for the quality completion of appropriate sections of Case Report Forms
To assist in / perform the administration of study medication
To monitor, interpret, communicate and manage adverse events and other clinical data throughout studies
To prepare safety reports for safety meetings and to attend such meetings
To perform clinical procedures as appropriate to each study
Excellent interpersonal, verbal and written communication skills
Client focused approach to work
A flexible attitude with respect to work assignments, new learning and travel.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with
attention to detail
Willingness to work in a matrix environment and to value the importance of teamwork.
IT literate – Experience with Microsoft based applications and general knowledge of PC functions.
Pressurised work environment – to deliver on competing agendas and deadlines. Work shift pattern is unpredictable and work is likely to be interrupted to deal with queries.
Knowledge and Experience :
Relevant clinical experience
An understanding of the International Conference on Harmonisation Good Clinical Practice (ICH GCP
Willingness to be Sub-I on selected studies within the EPCU