Clinical Research Associate I (West Coast: AZ, CA, NV, UT)
About The Position
Premier Research is looking for a Clinical Research Associate I to join our Global Clinical Monitoring and Site Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.
Requirements
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
- Patient facing, study coordinating experience preferred
- Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations, and drug/device development and clinical monitoring procedures
- Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where site monitoring activities will be conducted
- Ability to multitask and work effectively with technology and people in a fast-paced environment with changing priorities, self-starter
- Must be located in one of the following states: Arizona, California, Nevada or Utah
Responsibilities
- Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) timelines
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
- Monitors (remote, on site or other approved mode of monitoring) with a focus on data integrity and subject safety in accordance with local/regional laws and country specific regulations
- Plans day-to-day activities for monitoring of a clinical study and sets priorities per site
- Prepares for and conducts on site and/or remote qualification, study initiation, interim monitoring, dosing observation, and close out monitoring visits as directed per CMP
- Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
Benefits
- health insurance
- retirement plans
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
