Clinical Research Associates | Jobs | Australia - OzDial.com.au
Clinical Research Associates
Job Id :3583-2316-28690469
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CTI Clinical Trial & Consulting Services Australia Pty Ltd.

  • Full time
  • Sydney New South Wales, Australien

Job Summary: As a Senior CRA you will be responsible for the successful conduct of clinical trials and serve as main contact for the investigative site by representing CTI in a professional manner.

Job Details: What You’ll Do
Serve as main CTI contact for assigned study sites
Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP
Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection
Collect, review and track essential/regulatory documents
Participate in and complete all general and study specific training as required
Participate in investigator, client and project team meetings; may include presentations
Create and implement subject enrollment strategies for assigned study sites
Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan
Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
Assist with project-specific activities as member of Project Team
What You Bring
3 years clinical research experience as a CRA or related profession
Life science background
Excellent knowledge in ICH-GCP and regulatory requirement
Fluent in English
Why CTI?
We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade
Our culture is unparalleled – Click here to learn more about “The CTI Way”
We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program)
We are looking toward the future – We have had a consistent 15% growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate
Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

After an appropriate period of training, we offer you an unlimited, varied and attractive job in an international company.

Are you interested? Then we look forward to your electronic application or send your CV per email to Samy Weise

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