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Senior Research Physician, Principal Investigator

Employer
Parexel
Location
Harrow, United Kingdom
Salary
Competitive
Start date
15 Nov 2019
Closing date
15 Dec 2019

View more

Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


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.


Qualifications

Skills:
  • 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 Skills
  • Fluent written and spoken English.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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