About The Position

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp Our Fortune 500 Pharmaceutical client has an exciting opportunity for a Clinical Research Associate (CRA). Job Summary: The Clinical Laboratory Services (CLS) team of our client currently has a business need for surge capacity coverage for delivery based Clinical Research Associate (CRA) roles. This surge capacity model would utilize US-based contractor CRAs to focus on specific tasks/deliverables. The CRAs would not be trained on study startup activities but would be the single point of contact representing CLS to study teams and TPOs throughout study maintenance and closeout. The CRA will be based in Indiana (working at the client’s headquarters with the option of up to 50% remote work after training is complete).

Requirements

  • Bachelor’s degree
  • 6+ years of experience in the Clinical Industry
  • Clinical Research Assistant/Coordinator experience
  • Local to Indiana
  • Demonstrated ability to communicate clearly
  • Demonstrated attention to detail and organization
  • Skilled in Microsoft Excel for report combining and tracking

Responsibilities

  • Study level project management – including maintenance, data lock and closeout, document flow (review/approvals), budget management
  • Single point of contact for study teams and CLS TPOs
  • Tracking of safety, biomarker, PK and ADA samples as well as imaging and connected devices
  • Query tracking and management
  • Internal & External Engagement - Collaborate with internal business partners regarding CLS processes and business operations
  • Collaborate with business partners and TPOs to ensure data delivery
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