Senior Clinical Research Associate I
7 months ago
We believe in the power of partnership to fuel insights and unlock new possibilities. We offer our customers a tailored approach to clinical trial solutions through the use of three delivery models: full service, functional service providers, or a hybrid approach. We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. With our 30-year history, Fortrea's team of more than 19,000 professionals partner with emerging and large biopharma, medical device, and diagnostic companies to support operations and drive healthcare innovation, advancing life-saving therapies for patients in nearly 100 countries.
We are seeking a Senior Clinical Research Associate I (SCRAI) to join our clinical operations team that monitors Phase I - IV clinical trials.
**Responsibilities**:
- Lead all aspects of study site monitoring according to Labcorp Drug Development SOPs, GCP, and ICH guidelines
- Single Sponsor dedicated
- Partner with investigators and study coordinators on pre-study qualification and site initiation visits
- Conduct routine study site monitoring visits
- 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
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Advanced site monitoring skills
- Advanced study site management skills
- Advanced registry administration skills
- Works efficiently and effectively in a matrix environment
- Valid Driver's License
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.
**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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