Clinical Research Associate

4 weeks, 1 day ago
Full-time
Junior
Quality Assurance and Testing
Orca Bio

Orca Bio

Orca Bio is revolutionizing allogeneic cell therapy with next-gen therapies for better outcomes and fewer risks, transforming lives through precision and innovation.

Pharmaceuticals
51-250
Founded 2016
$192M raised

Description

  • Serve as the primary monitor and point of contact for assigned clinical sites.
  • Conduct interim monitoring visits and investigator site file reviews.
  • Review electronic medical records and patient data.
  • Perform source documentation verification against case report forms and communicate data errors or protocol deviations.
  • Verify adverse events, serious adverse events, concomitant medications, and related illnesses for accurate reporting.
  • Support research coordinators, physicians, and other site staff.
  • Help develop trial materials, monitoring guidelines, site tools, and training guides.
  • Contribute to Clinical Operations SOPs, best practices, work instructions, tools, and templates.
  • Author and submit monitoring visit reports within required timelines.
  • Maintain complete and accurate monitoring documentation in the eTMF.

Requirements

  • BA/BS degree or equivalent.
  • 2+ years of CRA experience, or 5+ years with lead monitor responsibilities for the Senior CRA role.
  • Prior sponsor-side CRA experience with primary site ownership and independent monitoring responsibility; startup experience preferred.
  • Oncology/hematology and cell and gene therapy experience preferred.
  • Strong knowledge of FDA and ICH-GCP regulations, guidelines, and clinical monitoring procedures.
  • Experience managing Trial Master Files according to the DIA reference model.
  • Experience working with site EMR/EHR systems.
  • Experience using eTMF, EDC, CTMS, and vendor systems or portals; IBM Zelta experience preferred.
  • Strong organization, prioritization, communication, problem-solving, and documentation skills.
  • Ability to work independently and collaboratively in a fast-paced startup environment; approximately one or more site visits per week may be required.

Benefits

  • Pre-IPO equity and annual bonus eligibility.
  • Competitive medical, dental, and vision benefits.
  • Paid time off and parental leave.
  • 401(k) plan.
  • Life and accidental death and disability coverage.
  • Subsidized daily lunches and snacks at on-site locations.
  • West Coast or East Coast role options with remote-based flexibility.

Interested in this position?

Apply directly on the company website

Apply Now

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