The successful candidate will be an experienced, self-motivated CTA/Sr CTA to support the day-to-day Clinical Operations functional activities associated with the execution of ongoing clinical trials outsourced to third party Vendors and CROs.

Job Duties include

  • Assist the Clinical Team Leader (CTL) to prepare and maintain Trial Master Files (TMF) for multiple studies, ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents. Inform the CTL/Project Team on any outstanding document/s
  • Develop knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of sample manifests
  • Develop and maintain tracking spreadsheets with study level information to enable accurate and efficient supply of clinical drug product (IMP) and clinical supplies to Sites, Vendors and CROs
  • Support financial oversight of clinical studies through invoice tracking and reconciliation for potential change orders
  • Day-to-day contact with counterpart at outside Vendor, CRO and/or trial site; daily review and identification of potential issues or problems and communicate/escalate to CTL/Project Team
  • Tracking of patient and recruitment status using applicable spreadsheets and web portal tools
  • May assist in the review of key study documents (e.g., Protocol, ICF, study plans, eCRF)


  • Effective time management and organizational skills
  • Attention to detail and accuracy in work
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • General working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
  • Computer skills, including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint
  • Demonstrates ability to manage components of clinical trials with general guidance from CTL
  • 3-6 years of Clinical Operations experience and a 2-year degree or 1-3 years Clinical Operations experience and a 4-year degree (BS or BA)


Xencor Inc. is an innovative biotechnology company headquartered in the Los Angeles area near Pasadena and with an office in San Diego. We recently completed a successful initial public offering (IPO). We use our pioneering XmAb® technology to develop better biotherapeutics — antibodies that target new biological mechanisms and are more potent, safer and longer lasting — to improve patient outcomes and quality of life.

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