Ref #: 28781

Employment type: Permanent - Full-Time

Location: Sydney, Australia

Posted: 28-Apr-2021


If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a Clinical Research Associate I to work closely with our client, a leading pharmaceutical company.

The Study Start Up Specialist is responsible for the preparation and approval of country or site-related submission packages in accordance with ICH, GCP and all applicable regulations, laws and guideline and ethical standards
The ideal candidate is also responsible for review and approval of site level critical documents for site activation in accordance with regulatory/ sponsor requirements- within timeline and quality standards

Key Responsibilities
Ethics, regulatory and other relevant authority approvals for clinical trials and non-interventional studies
Ethics, regulatory and other relevant authority approvals for trial amendments
Ethics, regulatory and other relevant authority study notifications
Approvals from the national authorities for data protection
Perform independent quality review of submission packages

Required experience and qualification
• BA/ BS/ BSC in life sciences or RN
• Experience working as a CRA ( working on industry sponsored or industry partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company

Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients.