Clinical Research Associate Role available with a leading CRO - Across Sydney /Melbourne.
They have worked on 90+ marketed drugs across multiple therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.they are growing rapidly , their workforce is comprised of over 10,000 employees, expanding across 13 time zones across six continents
CRO in either the Core team or with a global Sponsor. The roles are Home Based/Office based. Across Sydney /Melbourne.
To enable success in this position you will have:
- Independent monitoring -Local experience at least 2-3 years.
- Prior working exposure in a CRO environment and knowledge of ICH-GCP guidelines as well as submission.
- Perform routine site visits, including Pre-study, initiation, routine and closeout visits. Visits to include monitoring or proper informed consent procedures, compliance and assurance of good site performance
- Document each visit with a quality written monitoring visit report and submit to the reviewer for review and approval within contractual guidelines
- Review and approve monitoring visit reports ensuring finalization within contractual obligations.Perform monitoring evaluation visits with Junior CRA.
- Present study materials at investigator/study launch meetings when required.
- Core Team or with Global multi sponsors Sponsor
- Home/Office based - flexibility
- Competitive remuneration package with excellent benefits
- Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organisation
- Opportunity to work within a successful and rewarding environment