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Posted 12 days ago

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Clinical Research Associate

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AI Summary

Monitors clinical trials for a cell-therapy company, conducting site visits and remote oversight to ensure protocols, GCP, and regulatory requirements are met.

About this role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Summary of Role: In this Clinical Research Associate role, you will be responsible for monitoring the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

We are recruiting for two roles: one based on the West Coast and one based on the East Coast. Travel expected: ~1+ site visit per week, for sites that do not permit virtual monitoring.

Responsibilities:

  • May serve as the primary monitor and main point of contact for assigned clinical sites
  • Conduct interim monitoring visits (IMVs) and ISF review
  • Review electronic medical records (EMR)/patient data
  • Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
  • Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
  • Provide support to site staff including research coordinators and physicians
  • Assist in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides)
  • Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates
  • Author and submit high-quality monitoring visit reports within required timelines
  • Ensure completeness and accuracy of monitoring documentation in the eTMF

    • Qualifications:

  • BA/BS or equivalent with a minimum of 2+ years of CRA experience (for CRA role) or 5+ years with lead monitor responsibilities (Senior CRA)
  • Therapeutic experience in oncology/hematology and cell and gene therapy preferred
  • Prior CRA experience working directly for sponsor, ideally a start-up/or small company, with primary site ownership and independent monitoring responsibility
  • Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
  • Experience with Trial Master File management according to the DIA reference model
  • Experience operating within various site EMR/EHR systems
  • Experience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals, as well as working on trials without a CTMS in place

    • Personal Qualities:

  • Highly detail oriented with special attention to quality and quality control
  • Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
  • Well organized and able to work under tight deadlines
  • Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
  • Strong interpersonal skills, including verbal and written communication, are essential
  • Ability to work in a collegial and collaborative manner; independently and as part of a team
  • Ability to work in a fast-paced and informal startup environment
  • Highly tolerant and respectful of all members of our team
  • Strong problem-solving skills with desire to improve upon established processes
  • Sense of humor

    • Skills

    Adverse Event ReportingCase Report FormsCTMSDIA Reference ModelEDCEMR/EHRETMFFDA RegulationsIBM ZeltaICH-GCPIMVMonitoring Visit ReportsSDVSOPs

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