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Clinical Research Associate
5 months ago
Job Title : Clinical Research Associate
Location : San Diego, CA 92121 100% in person
Duration : long term position
Day Shift : Mon – Fri 09:00 AM – 05:00 PM
Job Description:
- Apply knowledge of FDA regulations to site monitoring and clinical study design duties.
- Monitor and maintain necessary supplies, with approval by senior department staff.
- Maintain effective, professional, timely, and consistent communications with clinical sites both in person, and via all available correspondence media (telephone, email, web, etc.)
- Support and/or lead clinical research study start up activities (includes creation of study binders, study logs, work instructions, case report form, and other study related materials)
- Ability to train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, testing and shipping, data entry and query resolution.
- Study monitoring (includes assessing the familiarity of the site personnel with the protocol, procedures, and investigational product, assessing protocol compliance and investigational product accountability as applicable, source document verification, identifying protocol deviations, writing queries, writing monitoring reports, notes to file, and other documentation as necessary)
Job requirements:
Top 3 skills you’re looking for on resume:
- on-site and remote monitoring experience 2-5 years.
- experience with study start up, monitoring, and close out activities
- ability to work independently, get training done and able to hit the ground quickly.
