Senior Clinical Research Associate
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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
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