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Senior Clinical Research Physician [Principal Investigator]

Employer
Parexel
Location
Harrow, United Kingdom
Salary
Competitive
Start date
23 May 2023
Closing date
22 Jun 2023

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

Job Details

Are you currently a non-First in Human (FIH), Principal Investigator (PI)?

Are you looking for a development opportunity to become PI, (FIH)?

We have an exciting opportunity for a PI whose primary responsibility will be to provide medical support for human volunteer studies of new and existing pharmaceuticals performed in an Early Phase Clinical Unit (EPCU) in Harrow. We are happy to support with the educational and training requirements associated with this position.

Key Accountabilities:
  • To perform the duties of Principal Investigator on non-First in Human clinical trials according to International Conference on Harmonisation (ICH) Good Clinical Practice and to the highest standard to ensure that the welfare of the trial participants 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 London EPCU.
  • To ensure that trial participants give fully informed consent in writing before commencing a study.
  • To perform pre-study medical histories and medical examinations for studies performed in the London EPCU and to decide on a trial participant’s suitability for inclusion in a study and for joining the EPCU volunteer panel.
  • To liaise with hospital specialists, GPs, consultants, and others to recruit suitable volunteers and patients for clinical trials.
  • To assess and interpret study clinical data, e.g., Heart rates, BP, ECG’s, laboratory tests, adverse events etc.
  • To monitor, interpret, communicate, and manage adverse events and other clinical data throughout studies.
  • To be responsible for the quality of completion of appropriate sections of Case Report Forms.
  • Meeting with Monitors and dealing with query resolution and clarifications appropriately.
  • To prepare, review and QC safety reports for safety meetings.
  • To perform clinical procedures as appropriate to each study
  • To perform / assist in the administration of study medication


Department administration:
  • To be involved in quality audits, QI management, root cause analysis and CAPA plans
  • To be involved in SOP updates and processes
  • To attend and be involved in study or corporate meetings


Training:
  • To provide study specific training to the study team as appropriate, and delegate resources to the studies.
  • Maintains own training and compliance as per role curriculum.
  • Works towards obtaining FIH PI status


Knowledge/Skills & Experience:
  • Preference for 4 years of experience in patient care post-medical qualification
  • At least 18 months clinical experience and training in a phase 1 unit, with supervision by an experienced clinical pharmacologist / Phase1 Unit Medical Director highly advantageous
  • Excellent interpersonal, verbal, and written communication skills
  • A flexible attitude with respect to work assignments, new learning, and necessary shift work.
  • Ability to work under pressure. Resilient to an unpredictable work shift pattern and dealing with interruptions.
  • Willingness to work in a matrix environment and to value the importance of teamwork.
  • Good written and spoken English


Education
  • Medical Doctor with a full valid registration at the General Medical Council with license to practice
  • Preferably attained at least one of the following:
    • Diploma in Pharmaceutical Medicine (DipPharm Med)
    • Member of the Faculty of Pharmaceutical Medicine (MFPM), FFPM or DCPSA
    • Medical research qualification, such as MD or PhD in pharmacology
    • Other relevant Human Pharmacology qualification
    • Other relevant post graduate medical qualification

Company

parexel

When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

How to describe Parexel’s culture in one word: 

Henry

 

 

Working With Heart™ - Christina's perspective:

Working With Heart™ - Christina's perspective:

 

Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 

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

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