Clinical Research Associate Ii

2 weeks ago

Port Melbourne, Australia Labcorp Full time

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

We are seeking a Clinical Research Associate II (CRA2) I to join our clinical operations team that monitors Phase I - IV clinical trials.

**Responsibilities**:

- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties as assigned
- Partner with investigators and study coordinators on pre-study qualification and site initiation visits
- Conduct routine study site monitoring
- Close-out clinical sites and ensure study files are up to date to maintain the success of the study.

**Experience**:

- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
- Thorough knowledge of regulatory requirements
- Thorough understanding of the drug development process
- Intermediate to advanced clinical monitoring experience
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Advanced study site management skills
- Advanced registry administration skills
- Valid Driver's License

**What we offer**:

- Career progression and pathway to become a Clinical Team Lead /Project Manager
- Competitive remuneration package
- Friendly and inclusive team environment

If you are passionate about Clinical Research and a person who has experience independently monitoring Phase I - IV clinical study sites in Australia, let’s talk as we may have a job for you.

Labcorp Australia is committed to providing you the flexibility to work from home, the freedom to grow & develop your career across all phases and areas of clinical trial operations, as well as provide state of the art technology and processes that help to give you time back to enjoy family life.

**Did you know?**

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

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