We are seeking exceptional Senior Clinical Research Associates (CRAs) with independent site monitoring experience to join our growing Clinical team in New Zealand.
If you are passionate about Clinical Research and a person who has experience independently monitoring global Phase I - IV clinical study sites across Australia, let’s talk as we may have a job for you.
As a Senior Clinical Research Associate at Labcorp you will:
- Lead all aspects of study site monitoring according to GCP, and ICH guidelines
- Partner with investigators and study coordinators on pre-study qualification and site initiation visits
- Conduct routine study site monitoring visits across Australia
- Close-out clinical sites, and ensure study files are up to date to maintain the success of the study
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
- In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.
- Thorough knowledge of regulatory requirements
- Thorough understanding of the drug development process
- Fluent in local office language and in English, both written and verbal
- Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Two (2) years of Clinical Monitoring experience
- 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
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritizes workload for self and team
- Ability to work within a project team
- Works efficiently and effectively in a matrix environment
- Valid Driver's License
- One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
- Local project coordination and/or project management experience
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