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Company Contact Info

  • Foster City, CA 94404
  • Joseph Lindeman

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Clinical Records Associate I

Kelly Scientific Resources • Foster City, CA

Posted 1 month ago

Job Snapshot

Full-Time
Degree - 4 Year Degree
Other Great Industries
Biotech, Research, Science

Job Description

Job Title: Clinical Records Associate - I Description: • Maintain an minimal understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records. 
• Participate in continued security and maintenance of the Trial Master File (TMF) Room. 
• Participate in offsite storage activates. 
• Create and maintain study specific file structures for Gilead clinical, biometrics, and preclinical documents and file documents accordingly. 
• Ensure record filing is kept up to date and is performed accurately. 
• Perform an inventory review for incoming CRO clinical study files; receive, index, and file preclinical study records; responsible for offsite archival of documents; participate in periodic file room utilization reviews; file incoming documents and retrieve documentation from the TMFR upon request. 
• May provide support during TMF-related regulatory agency and internal GCP inspections readiness. 
• Assist in the development of electronic tracking/ filing systems. Requirements:

  • Bachelors degree in a related field
  • Familiarity with DIA reference model preferred 
  • 1-2 years experience preferred
  • Excellent communication
  • Attention to detail
  • Eagerness to learn




Why Kelly®?


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.



About Kelly Services®


As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

Job ID: US15TPJL_BH1578838
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