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Clinical Trial Specialist in San Rafael, CA at APEX Systems

Company: Apex Systems
Location: San Rafael
Posted on: May 19, 2019

Job Description:



Job Description

Job #: 960405

Apex Systems is looking for a--Clinical Trials Specialist--in--San Rafael, CA--for one of our large biotech clients.

If you meet the qualifications below, please reach out to recruiter Azriella Kilgore at akilgore@apexsystems.com.

Duties:

We are currently looking for the best and brightest talents to join our team. The ideal candidate would be a clinical research professional passionate about operations with a minimum of 2 years experience in Clinical Operations, focused on working to ensure delivery of quality data, and committed to helping our patients. A proactive problem solver who shows flexibility and an ability to communicate at all levels of an organization.


  • Performs essential responsibilities for successful trial execution.
  • Takes on the key role of Study Specialist, contributing to tasks related to site management and/or study management and oversight activities as delegated by SETL, Study Operations Lead (SOL), or Regional Operations Lead (ROL).
  • Contributing to and/or supporting study matters that impact study timelines, quality and budget.--
  • Assist with study coordination activities
  • Conduct study tracking support (e.g., CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates
  • Assist with inspection readiness activities File, track and maintain TMF Maintain internal/external contact list
  • Conduct electronic documentation and records management
  • Perform document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, payments, invoices, and other study documentation
  • Execute meeting logistics (e.g., meeting minutes, expense reports, and travel coordination)
  • Ensure timely study entry and updates to ClinicalTrials.gov
  • Prepare investigator meeting materials
  • Design and prepare study related materials for the training of internal and external staff
  • Assist or lead in study conduct activities


    Start-up:


    • Facilitate CDA and contract execution.
    • Assist with regulatory package review
    • Request and distribute insurance certificates for sites - as delegated by, and under the oversight of, Study Lead Contact and identification of investigators for participation in clinical studies
    • Provide administrative assistance with internal and external meetings including investigator meeting(s)
    • Assisting in the management of CRO deliverables (from meeting minutes to finalized ICF)
    • Ensure accurate study entry and updates to ClinicalTrials.gov throughout life of study


      Enrollment and Maintenance:


      • Issues identification, resolution, and escalation
      • Track site payments and vendor invoices
      • Track patient status
      • Review of study ICFs and other study documents
      • Assist with samples reconciliation and query resolution
      • Conduct MVR review and appropriate escalation of identified issues
      • Assist with MVR tracking and filing of sponsor comments
      • Identify issues, with potential resolution, and escalate when appropriate


        Closure:


        • Conduct study closure activities (sites, reconciliation activities, filing & archiving)
        • Track, collate clinical trial documentation related to CSR appendices Cross-functional Representation
        • Assist with cross-functional meeting coordination and minutes
        • Assist study supplies management Lead TMF close-out activities, including document review, uploading and reconciliation--


          Skills:


          • he Clinical Trial Specialist is expected to be in the process of developing foundational competence in critical areas required for success in Clinical Operations across Communication and Collaboration, Proactivity and Adaptability, Strategic Thinking, Planning and Analysis, and Problem solving and Decision Making.
          • Responds promptly with clear, organized written and oral communication
          • Seeks out, and understands the value of, opportunities to interact with peers and stakeholders; builds a network of internal and external peers
          • Takes ownership and accountability for completing assigned tasks and perseveres through obstacles
          • Embraces new challenges or changed priorities and adjusts plans and priorities accordingly
          • The Clinical Trial Specialist is also in the process of developing foundational technical competence in Study Management and Execution, Compliance and Quality, Drug Development and Study Design, and Product and Therapeutic Area Knowledge.


            Education:


            • BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered. 2+ years pharmaceutical industry experience--


              EEO Employer

              Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.


Keywords: Apex Systems, San Rafael , Clinical Trial Specialist in San Rafael, CA at APEX Systems, Healthcare , San Rafael, California

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