Senior Clinical Research Physician

5 days ago

King of Prussia, United States Parexel International Corporation Full time

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
RequiredPreferredJob Industries
  • Other

  • Senior Clinical Research Associate

    5 days ago

    King of Prussia, United States Parexel International Corporation Full time

    Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep...

  • Senior Clinical Research Associate

    5 days ago

    King of Prussia, Pennsylvania, United States Parexel International Corporation Full time

    Parexel International Corporation is a leading Clinical Research Organization that improves the world's health by providing biopharmaceutical services. Our global team transforms scientific discoveries into new treatments through clinical trials, regulatory, consulting, and market access services.About the RoleWe are currently seeking an experienced Senior...

  • Senior Emergency Physician in Pennsylvania

    2 days ago

    King of Prussia, Pennsylvania, United States Physician Empire Full time

    Physician Empire - A Leading Healthcare InstitutionWe are seeking a highly skilled and dedicated Senior Emergency Physician to join our team at our state-of-the-art facility in Pennsylvania. As a key member of our emergency medicine department, you will play a vital role in providing high-quality care to our patients.About the PositionThis is a full-time...

  • Director Clinical Research Hematology

    2 weeks ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Hematology Clinical Research Lead Position

    1 week ago

    King of Prussia, Pennsylvania, United States CSL Behring Full time

    CSL Behring is a leading biotechnology company that specializes in developing and delivering innovative therapies for patients with rare and serious diseases. As a global organization, we operate in over 35 countries and employ approximately 30,000 people worldwide.We are seeking a highly skilled Director Clinical Research to join our team in King of...

  • Director Clinical Research Hematology

    1 month ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Senior Clinical Research Physician

    6 days ago

    King Of Prussia, United States Parexel International Corporation Full time

    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...

  • Senior Research Scientist

    6 days ago

    King of Prussia, Pennsylvania, United States Talent Groups Full time

    Talent Groups is seeking a highly skilled and motivated Senior Research Scientist - Clinical Supply Chain to join our team.Job Description:The successful candidate will be responsible for participating in all aspects of department visual inspection program, including preparation of the inspection suite, stocking of related supplies, performance of inspection...

  • Clinical Research Nurse Specialist

    5 days ago

    King of Prussia, Pennsylvania, United States Parexel International Corporation Full time

    Parexel International Corporation OverviewParexel Early Phase Clinical Unit supports the development of innovative new medicines, which are vital for public health, improving outcomes, and saving lives.Job Title: Clinical Research NurseKey Responsibilities:Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to...

  • Director Clinical Research Hematology

    1 month ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Research Hematology

    3 weeks ago

    King Of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and 30,000 employees worldwide, CSL is inspired to develop and deliver a...

  • Director Clinical Research Hematology

    1 month ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Research Hematology

    1 month ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Research Hematology

    1 month ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Research Hematology

    1 month ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Research Hematology

    3 weeks ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Clinical Research Nurse

    5 days ago

    King of Prussia, United States Parexel International Corporation Full time

    Parexel Early Phase Clinical Unitsupports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and "first in human" trials are the first step in testing these novel treatments in humans.At Parexel Glendale Unitour highly trained and skilled nurses are the front-line staff...

  • Clinical Research Nurse

    3 months ago

    King of Prussia, United States PAREXEL Full time

    Parexel Early Phase Clinical Unitsupports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and "first in human" trials are the first step in testing these novel treatments in humans. At Parexel Glendale Unitour highly trained and skilled nurses are the front-line staff...

  • Clinical Research Nurse

    5 days ago

    King of Prussia, United States PAREXEL Full time

    Parexel Early Phase Clinical Unitsupports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and "first in human" trials are the first step in testing these novel treatments in humans. At Parexel Glendale Unitour highly trained and skilled nurses are the front-line staff...

  • Clinical Research Nurse

    3 months ago

    King of Prussia, United States PAREXEL Full time

    Parexel Early Phase Clinical Unitsupports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and "first in human" trials are the first step in testing these novel treatments in humans. At Parexel Glendale Unitour highly trained and skilled nurses are the front-line staff...