Clinical Trial Associate

Company: Arcellx
Location: Redwood City
Posted on: January 24, 2023

Job Description:

Arcellx, Inc. (http://www.arcellx.com/) is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and our mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Our offices are located in Gaithersburg, Maryland, and Redwood City, California.

Arcellx's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (r/r MM) in an ongoing study. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration.

Arcellx is also advancing its dosable and controllable CAR-T therapy, ARC-SparX, through two programs: ACLX-001 for relapsed or refractory multiple myeloma and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

Arcellx is looking for a Clinical Trial Associate to join our dynamic team. In this role, the CTA will provide highly organized and detail-oriented support to the Clinical Project Manager and study team with active participation in the overall management of clinical trials, including planning, execution, and closeout of one or more outsourced clinical trials in a fast-paced environment. You will create, maintain, and distribute study team materials, track the status of projects, review and maintain documents, assist in the management of clinical study vendors, completing tasks accurately and timely and in accordance with SOPs, ICH GCP, and FDA CFR.

At Arcellx, we value passion, curiosity, determination, and diversity, and look for candidates who demonstrate a genuine interest in our mission and alignment with our values.

Key Responsibilities:

• Schedule activities and meetings, including compilation of materials and presentations.
• Assist with the management of vendors.
• Set-up, organize and maintain project SharePoint (folders, documents).
• Prepare and distribute meeting minutes for both internal and external meetings as well as review meeting minutes from others for accuracy.
• Review and submit documents for the TMF from sponsor study team.
• Create, distribute, and update trackers and dashboards, and report on key deliverables and metrics.
• Proactively identify potential study issues/risks and recommend/implement solutions; ensure issues are escalated as appropriate.
• Assist in the resolution of study questions from CRO and clinical trial sites.
• Support logistics for the study team (e.g., manage and track clinical and nonclinical supplies).
• Assist in biological sample specimen reconciliation and management.
• Support departmental initiatives and process improvements.
  Skills, Knowledge, and Abilities:
  
  • Ability to communicate clearly both verbally and in writing to sites, vendors, CROs, internal study team, etc.
  • Ability to plan, organize, and manage multiple priorities and/or projects in a fast-paced environment.
  • Attention to detail, quality and accuracy of work, and able to independently follow up on assigned items.
  • Strong analytical and problem-solving skills.
  • Familiarity navigating tracking systems and tools or clinical studies, e.g., EDC, IRT, CTMS.
  • Ability to create and maintain partnerships with a multiple disciplinary internal clinical team as well as in interactions with CROs/vendors.
  • Knowledge and application of ICH GCP, and FDA regulations in day-to-day activities.
    Requirements:
    
    • BS/BA/RN in nursing, science or health field and at least 2 years of relevant experience in the biotechnology or pharmaceutical industry.
    • Versatile with MS Office applications including Outlook, Word, Excel and PowerPoint
      Competencies:
      
      • Has character and integrity. Committed to always doing what's right.
      • Self-motivated and able to work autonomously. Can produce top-quality work with little oversight.
      • "No job is too small" mentality. Humble and willing to help others.
      • Able to build strong relationships and collaborate effectively with colleagues.
      • Gives direct, candid, and respectful feedback. Can receive feedback with curiosity and without getting defensive.
      • Always looking to improve and challenge the status quo. Gritty and determined.
        Salary Range: $86,000 - $115,000 per year.

Keywords: Arcellx, Redwood City , Clinical Trial Associate, Healthcare , Redwood City, California