Senior Clinical Research Associate

Posted 70ds ago

Employment Information

Education
Salary
Experience
Job Type

Report this job

Job expired or something wrong with this job?

Job Description

Senior Clinical Research Associate monitoring clinical trials for biopharmaceutical and biotechnology industries. Ensuring compliance with regulations and collaborating across project teams.

Responsibilities:

  • Monitor clinical trials according to monitoring plans to achieve project goals
  • Conduct or assist with site evaluations, study initiations, routine monitoring and site close-outs
  • Work with the study start up team and site staff to obtain regulatory approval of study specific documents
  • Perform data review activities, collaborate with data management to identify trends and implement corrective action to enhance data quality
  • Ensure compliance with appropriate regulations and guidelines throughout the trial
  • Participate in project audit/inspection preparation and conduct

Requirements:

  • University/college degree in life sciences preferred (or the equivalent of 5-6 years industry experience)
  • Minimum of 5 years CRA direct monitoring experience with a sponsor company or CRO
  • Strong knowledge of Australian clinical trial regulations and ICH GCP guidelines
  • Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs
  • Proficient with Microsoft Office Suite
  • Ability to travel up to 70% as needed

Benefits:

  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Professional development opportunities