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Pfizer

Pfizer is a leading biopharmaceutical company headquartered in New York, New York. Over the years, Pfizer has received numerous awards and accolades for its bus

Senior Clinical Research Associate I

Location

United Kingdom

Posted

1 day ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglish

Job Description

Senior Clinical Research Associate I

Pfizer

• Responsible for investigator site management and monitoring for assigned sites • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pfizer standards to achieve project goals, timelines and quality • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met • Serve as the primary point of contact for assigned investigator sites during study conduct. • Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites • Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and safeguarding of patients; include protocol training and address protocol related questions from investigator site staff when required. • Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities ensuring adherence to the Study Monitoring Plan, SOPs and commensurate with emerging issues and technologies. • Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution.

Job Requirements

  • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
  • Minimum 3 years relevant experience in clinical research site monitoring (some experience in Oncology)
  • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
  • Global clinical trial experience
  • Must be fluent in English and in the native language(s) of the country they will work in.

Benefits

  • Significant travel (60-80%) within area is required.
  • May require some international travel and some weekend travel

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