California - US Full Time 1 week ago

A Clinical Trial Coordinator position in South San Francisco, CA is available through Adecco Medical & Science.
 
Project Overview:
The Product Evaluation team sits within the Client’s Clinical Development team and is made up of clinicians, clinical operations specialists, and program managers. Product Evaluation helps teams across client’s product portfolio design and execute human-facing research to assess feasibility, usability and performance at early stages of the product development lifecycle. As a Product Evaluation Clinical Coordinator, you will be integral to the execution and logistics of studies that power R&D to guide product development.
 
Overall Responsibilities:

  • Assists Study Manager in managing day-to-day responsibilities of clinical studies at investigational sites
  • Responsible for coordinating and leading various functional and cross-functional projects and tasks
  • Assists in developing protocol and informed consent form and other study-related documents using knowledge of GCP/ICH and other regulatory requirements
  • Assists study manager with the investigator contract, budget, and payment process 
  • Responsible for initiating and tracking scheduling, payments, and subject compensation
  • Develops Case Report Forms (CRF), CRF guidelines and other study forms to be utilized by investigational sites
  • Proactively identifies and works to resolve enrollment and data completion issues
  • Performs manual, in-house review of CRF data for quality, completeness, and accuracy
  • Completes data entry and data resolution in clinical database
  • Coordinates and reviews regulatory documents from investigational sites as well as in-house to ensure compliance with protocol and applicable regulations
  • Initiates and tracks device shipments and dispositions and ensures that device supplies are adequate for investigational sites/assigned studies
  • Understands study timelines and manages investigational sites to meet enrollment goals and timelines
  • Presents at Investigator/Study Coordinator meetings, as needed 
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    Top 3 Daily Responsibilities:

  • Informed consent, study procedures and execution
  • Data entry
  • IRB packet preparation and submissions
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    Skill/Experience/Education:
     
    Education:

  • BS/BA degree in a life science, health science, RN, or related field
  • 2+ years of direct Clinical Research experience, or four years of industry experience including 1 year in Clinical Research in Diagnostic or Therapeutic Medical Devices.
  • 1+ years of experience in clinical research at either a hospital or Medical Device/ Pharmaceutical company
  •  
    Desired:

  • Combination Device experience a plus.
  • Good oral and written communication skills are required.
  • Superior attention to detail and organizational skills Working knowledge of GCP and FDA regulations
  • Proficiency in MS Word, Excel and Powerpoint Basic Data Analysis and Interpretation skills
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    If you are interested in this Clinical Trials Coordinator position in South San Francisco, CA role then please click APPLY NOW. For other opportunities available at Adecco Medical & Science please go to www.adeccousa.com .
     
    Equal Opportunity Employer/Veterans/Disabled. To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit [Link available when viewing the job] . The Company will consider qualified applicants with arrest and conviction.
     
     

    Equal Opportunity Employer/Veterans/Disabled

    To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to [Link available when viewing the job] />
    The Company will consider qualified applicants with arrest and conviction records

     

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