Clinical Trial Assistant

Clinical Operations · San Diego, California
Department Clinical Operations
Employment Type Full Time
Minimum Experience Entry-level

Xencor is an innovative, clinical-stage biopharmaceutical company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics – antibodies and other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for a Clinical Trial Administrator to join our team.

 

Our capabilities and the modular nature of XmAb technology allows us to quickly identify and create new platforms and drug candidates for potential development. We are developing a deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific antibody and cytokine technologies. Nine XmAb bispecific antibody programs are in clinical testing, and more are expected to start clinical testing in 2021. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. We and our partners are advancing 18 XmAb drug candidates through clinical development, and two medicines that incorporate XmAb technology are approved for commercial marketing.

 

The successful candidate will be an experienced, self-motivated Clinical Trial Assistant (CTA) to support the day-to-day activities of the assigned Clinical Trials. 

 

Job Duties include:

 

  • Assist the Clinical Trial Manager (CTM) to prepare and maintain Trial Master Files (TMF) for multiple studies, ensuring tracking of ICH-GCP and/or FDA 21CRF essential study documents. Inform the CTM/Clinical Team on any outstanding document/s

 

  • Develops 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 communicates/escalates to CTM/Clinical Team

 

  • Tracking of patient and recruitment status using applicable spreadsheets and web portal tools

 

  • May assist in the review of key study documents (eg, Protocol, ICF, study plans, eCRF)

 

 

Qualifications/Requirements:

 

  • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively

 

  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

 

  • Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint

 

  • Strong oral and written communication skills

 

  • Basic awareness of clinical trial regulations and processes

 

  • 1-2+ years required (CTA). Study coordinator from CROs or academic institutions will be considered

 

  • High school diploma (required); BA/BS degree in life sciences or similar field (preferred)

 

We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development.  With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume to recruiting@xencor.com.  For further information about Xencor, please visit our website at www.xencor.com   EOE

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  • Location
    San Diego, California
  • Department
    Clinical Operations
  • Employment Type
    Full Time
  • Minimum Experience
    Entry-level