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Australian Senior Clinical Research Associate Position Available
3 weeks ago
Senior Clinical Research Associate Role
">The role of Senior Clinical Research Associate is based in Australia and involves extensive onsite monitoring experience, including oncology. This position requires overnight travel (regional or national) depending on business needs.
">Key Responsibilities:">
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- Ensure compliance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability while performing and coordinating all aspects of the clinical monitoring and site management process.">
- Conduct remote or on-site visits to assess protocol and regulatory compliance, manage required documentation, and provide trial status tracking and progress update reports as required.">
- Participate in investigator meetings, identify potential investigators, and ensure the acceptability of qualified investigative sites.">
- Ensure that required essential documents are complete and in place, according to ICH-GCP and applicable regulations, conducting on-site file reviews as per project specifications.">
- Facilitate effective communication between investigative sites, stakeholders, and the project team through written, oral, and/or electronic contacts.">
Required Skills and Qualifications:">
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- Bachelor's degree in a life sciences-related field or equivalent formal academic/vocational qualification.">
- Minimal 4 years' experience in independent monitoring experience in Australia, providing the knowledge, skills, and abilities to perform the job.">
- Valid driver's license where applicable, with therapeutic experience in Oncology and Phase I experience essential.">