Clinical Research Associate

5 days ago

Macquarie Park, Australia AstraZeneca Full time

We’re investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical success.

**What you’ll do**

You are a self-motivated, proactive, and passionate individual focused on delivering quality outcomes in a fast-paced environment. The new Clinical Research Associate (initial 12 month contract, full-time basis), will be involved in effective site management across a number of high-profile studies as well as all aspects of the study from preparation, initiation, monitoring, and closure. To be successful in this role you will have good knowledge of Clinical Study Management across monitoring, study drug handling and data management. You will ideally have experience working in a similar capacity, have excellent knowledge of international guidelines ICH-GCP, relevant local regulations and a basic understanding of the drug development process.

**Key responsibilities include, but **not** limited to**:

- Contributing to the selection of potential investigators and training, supporting, and advising investigators in regards to study related matters including Risk Study start-up and regulatory maintenance
- Initiating, monitoring, and closing study sites in compliance with AZ Procedural Documents. This includes participating in Local Study Team (LST) meetings and sharing information on patient recruitment and study site progress Updating CTMS and other systems with data from study sites
- Performing monitoring visits (remotely and on site), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan
- Performing regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study

**Essential for the role**
- Bachelors degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of international guidelines ICH‐GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

**Desirable for the role**
- Ability to work in an environment of remote collaborators.
- Handles change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Good analytical and problem‐solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Familiar with risk‐based monitoring approach including remote monitoring.

**Why AstraZeneca**

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA). As an organisation we stand with confidence on our gender equality initiatives including pay equity, leadership development programs, and zero tolerance for gender-based harassment. This achievement exemplifies our commitment to building high performing, inclusive and diverse teams that collaborate across our enterprise, aligned to our values and strategic priority of being a Great Place to Work.

**So, what’s next?**
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant We have a seat available and we hope it’s yours.
- If you’re curious to know more than please get in touch with Stuart Gates.

**Where can I find out more?

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