Senior Clinical Research Associate I (Melbourne- home based)

Syneos Health

Adelaide

2 weeks ago

Adelaide

2 weeks ago

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Senior Clinical Research Associate I (Melbourne- home based)

Senior Clinical Research Associate I role at Syneos Health, a biopharmaceutical solutions organization. The position involves independent clinical monitoring, site management, and ensuring regulatory compliance, requiring a Bachelor's degree in Life Sciences and at least 4 years of experience. This is a remote, full-time opportunity based in Melbourne with home-based work.

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Remote

Full-time

Senior

ICH-GCP

Good Pharmacoepidemiology Practices

Salary

Not specified

Work Location

Adelaide, South Australia, Australia, AU

Work Model

Remote

Experience Required

4 years

Employment Type

Full-time

Experience Level

Minimum of 4-years of independent clinical monitoring experience

Core Qualifications

Technical (Must-have)

ICH-GCPGood Pharmacoepidemiology Practicesprotocol compliance

Soft Skills

communicationinterpersonal skillstime managementcritical thinking

Key Responsibilities

•Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed onsite or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
•Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
•Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
•Awesome line management supporting team with a huge focus on you!
•Value your expertise, listen to your voice and most important work as a team
•Forward thinking & innovative CRO which stands out in the industry

Clinical Research AssociateBiotechnology ResearchResearchAnalystInformation TechnologyClinical MonitoringCRALife SciencesRegulatory ComplianceRemote

Key Responsibilities

•Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed onsite or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.

•Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.

•Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

•Awesome line management supporting team with a huge focus on you!

•Value your expertise, listen to your voice and most important work as a team

•Forward thinking & innovative CRO which stands out in the industry