Senior Clinical Research Associate I
Syneos Health
Melbourne
2 weeks ago
Senior Clinical Research Associate I
Senior Clinical Research Associate I position at Syneos Health, a forward-thinking CRO. The role involves performing site qualification, initiation, monitoring, management, and close-out visits for clinical trials, ensuring regulatory and protocol compliance. Requires a Bachelor's degree in Life Sciences, 4+ years of independent clinical monitoring experience, and full working rights in Australia or New Zealand.
Remote
Full-time
Senior
ICH-GCP
Good Pharmacoepidemiology Practices (GPP)
Salary
Not specified
Core Qualifications
Technical (Must-have)
ICH-GCPGood Pharmacoepidemiology Practices (GPP)regulatory complianceprotocol complianceclinical monitoring
Soft Skills
communicationinterpersonal skillstime managementcritical thinkingjudgmentteamwork
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.
Senior Clinical Research AssociateCROclinical trialsICH-GCPsite managementremoteAustraliaNew ZealandBiotechnology