Clinical Research Operations Specialist

3 days ago

Melbourne, Victoria, Australia beBeeClinical Full time $100,000 - $140,000
Job Title: Clinical Research Associate

We are seeking a skilled Clinical Research Associate to oversee the management and administration of all aspects of clinical trials/studies involved in each step of the clinical study. This role will involve working closely with cross-functional teams to ensure timely completion of clinical trials.

Responsibilities:

  • Prepare protocols and other necessary documents required for trial approval by EC and obtain EC approval on time.
  • Monitor and coordinate the clinical trial conduction throughout the process by following GCP and SOP strictly.
  • Provide input for query resolution, site closure, and collection of documentation required for clinical trial reports after trial completion.
  • Ensure EDC/CTMS systems are updated in a timely and accurate manner according to requirements.
  • Report and follow up on all SAEs/adverse drug reactions in a timely manner according to internal SOPs.
  • Update investigator files and trial master files.
  • Build and maintain positive relationships with sites and investigators.
  • Ensure site visit reports and correspondence are completed on time.

The ideal candidate will have a Bachelor's degree in a biomedical/science discipline or equivalent, with at least 3-10 years of clinical operation monitor experience for senior positions. Good communication and organizational skills are also essential. The successful candidate will be able to work independently as well as part of a team and will have excellent problem-solving skills.

Requirements:

  • Bachelor's degree in a biomedical/science discipline or equivalent.
  • At least 3-10 years of clinical operation monitor experience for senior positions.
  • Good communication and organizational skills.

About Us:

We are a leading provider of clinical research services, dedicated to delivering high-quality results that meet our clients' needs. Our team is passionate about making a difference in people's lives through innovative research solutions.

What We Offer:

  • A competitive salary package.
  • Ongoing training and professional development opportunities.
  • A collaborative and dynamic work environment.

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