Senior Clinical Research Specialist

1 week ago

Armidale, New South Wales, Australia beBeeClinicalResearch Full time $90,000 - $120,000

Clinical Research Associate II Job Description

We are seeking a highly motivated Clinical Research Associate II to partner with investigator sites and ensure the proper conduct of clinical trials.

  • Manage operational aspects for implementation of clinical trial activities at assigned investigator sites.
  • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.
  • Provide protocol training to site personnel and address protocol-related questions from investigator site staff.

Responsibilities:

  • Clinical Trial Monitoring: Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.
  • Manage operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock.
  • Partner with SCP to perform investigator site development, coaching, and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients.
  • Monitor site-level AEs and SAEs and collaborate with the Drug Safety Unit to bring SAE reports to resolution.
  • Submit all required reports, documentation, updates, and tracking within required timeframes.

Required Skills and Qualifications:

  • Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent.
  • At least 2 years of relevant experience in clinical research site monitoring and management.
  • Global clinical trial experience is mandatory.
  • Must be fluent in English and in the native language(s) of the country they will work in.

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