Randstad Clinical Research Associate in San Diego, California

Clinical Research Associate

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job details:

  • location:San Diego, CA

  • salary:$30 - $55 per hour

  • date posted:Friday, August 4, 2017

  • job type:Temporary

  • reference:S_555571

  • questions:jacqueline.otis@randstadusa.com858-410-8000

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description

Randstad is seeking a Clinical Research Associate in San Diego, CA for one of its biotechnology clients. This position is office-based during non-travel time; candidates local to San Diego, or willing to relocate to San Diego will be considered. This client is a leading developer, manufacturer, and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood, and aid in biomedical research. You will work in an atmosphere that is stimulating, innovative, and customer focused.

Responsibilities:

  • Conduct Site Qualification, Initiation, and Interim Monitoring, Close-Out visits and activities in accordance with FDA Code of Federal Regulations, Good Clinical Practice, guidelines, departmental procedures and the Clinical Monitoring Plan (CMP)

  • Serve as primary site contact; establish and maintain regular communication with clinical sites

  • Train Investigators and site staff on protocol and study-specific processes

  • Assist with distribution, collection and tracking of essential regulatory documents for site compliance and audit readiness

  • Prepare and complete monitoring visit reports and letters, and effectively document site communications per the CMP

  • Review Informed Consent Forms (ICFs), completed Case Report Forms (CRFs), and other site documentation to verify subject protection, accurate data recording (source data verification), and adherence to the protocol and governing regulations

  • Identify and address routine site issues including protocol deviations and escalate to Study Lead (SL)

  • Review/complete quality control (QC) checks of Site Trial Master File (TMF)

  • Basic use of clinical databases and other associated data tracking tools

  • Demonstrate basic proficiency of the Clinical Trial Management System (CTMS)

Working hours: M-F, normal hours

Skills:

Qualifications

  • Bachelor's degree in related field

  • 2-4 yrs. External clinical site monitoring experience

  • Knowledge of clinical trial practices and regulations

  • Knowledge of clinical monitoring and trial design

  • Proficient use of clinical trial databases; proficient knowledge of technical computer systems

  • In Vitro Diagnostics (IVD) experience or medical device experience a plus

  • Experience with IBM Clinical Development a plus

  • Comfortable with 50% travel

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.