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Senior Research Physician, Principal Investigator

Parexel International Corporation

Harrow, England, United Kingdom

The primary responsibility of a Senior 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:To perform the duties of Principal 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 human volunteer 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.To decide on a Human 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 perform the duties of Principal 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 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 of completion of appropriate sections of Case Report Forms.To assist in / perform with 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.To perform clinical procedures as appropriate to each study.QualificationsSkills: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.Comfortable in a 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.IT literate – Experience with Microsoft based applications and general knowledge of PC functions.Knowledge and Experience:Relevant clinical experience and adequate experience in clinical research coupled with an understanding of the International Conference on Harmonisation Good Clinical Practice (ICH GCP)Education:Medical Doctor with a full valid registration at the General Medical Council with license to practice.Qualified to be PI on studies.Language SkillsFluent written and spoken English.

Job posted: 2021-08-26