Clinical Trials Administrator

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

Introduction:

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 cytokines with improved function, with the goal of improving patient outcomes and quality of life. We have an excellent opportunity for a Clinical Trials Administrator to join our team.

 

Our protein engineering capabilities and the modular nature of our XmAb technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are advancing a deep clinical pipeline of novel drug candidates, including eight bispecific antibodies and two engineered cytokines, and more programs are expected to start clinical testing in 2022. We also leverage our many XmAb technologies by collaborating with leading global biopharmaceutical companies, including Genentech and Janssen Biotech, among others, and including our partnerships, 20 XmAb drug candidates are advancing through clinical development. Three XmAb medicines, to treat patients with a range of serious illnesses, such as aggressive lymphoma, rare blood disorders and COVID-19, are now marketed worldwide by partners.

 

Our employees are the most important factor in our success, and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees’ value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.

 

Summary:

Responsible for assisting Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) by supporting the day-to-day activities of the assigned trials.

This is a hybrid role - working remotely with occasional in office visits in San Diego. Previous experience as a CRC or CTA is highly desirable.


Job Duties Include:

  • Supports the clinical operation team during study start-up, maintenance, and closure
  • Assists with preparation, maintenance and close-out of the Trial Master Files (TMF) for one or more studies
  • Performs routine reviews of the TMF to assure quality and completeness of documentation in compliance with Xencor SOPs, ICH-GCP and applicable regulatory requirements
  • Documents findings and trends identified during routine reviews of the TMF and communicates/escalates to the applicable project team members for resolution.
  • Supports TMF oversight activities, remediation of issues, and liaises with internal and external counterparts (e.g., CROs, trial site staff, Xencor departments, etc.) to ensure TMF remains audit and inspection ready.
  • Updates tracking spreadsheets with study information to support trial management (e.g., subject recruitment/enrollment, sample manifests, investigational product and clinical supplies, etc.)
  • Performs periodic review and/or reconciliation of various study related tracking sheets, reports, systems and/or portals, provides status updates, identifies potential issues and escalates to appropriate project team member(s) to facilitate resolution
  • Participates in project team meetings and TMF Operations meetings, and may assist in the preparation of meeting agendas, minutes, and tracking of action items
  • Adheres to all department and company-wide policies regarding conduct, performance and procedures
  • Performs other duties as required.

 

Job Qualifications:

Position minimally requires a high school diploma/GED with at least 1 year of related experience, a bachelor’s degree in a life sciences field preferred. Knowledge of applicable regulatory guidelines (i.e., ICH-GCP) and prior experience working in a small company in the biotech or pharmaceutical industry preferred.

The company reserves the right to consider internal experience in lieu of the education or experience requirements listed above.


Position also requires:

  • Good organizational skills and strong attention to detail
  • 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 skill
  • Basic understanding of clinical trial regulations and processes.

Physical, Mental and Environment Demands:

The physical, mental and working environment demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

 

The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.

 

Specific mental demands for the position are listed above under requirements.  In addition, mental demands for this position include:

  • Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
  • Ability to work and sustain attention with distractions and/or interruptions.
  • Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
  • Ability to maintain regular attendance and be punctual.
  • Ability to understand, remember and follow verbal and written instructions.


Occasional travel may be required, including travel between Xencor’s Monrovia and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

 

Xencor requires all employees to be fully vaccinated against COVID-19 as a condition of employment.  Being fully vaccinated means that at least two weeks have passed since an individual’s final dose of an authorized COVID-19 vaccine regimen, including any boosters recommended by the CDC.  New employees will be required to provide proof of their fully COVID-19 vaccinated status as of their start date unless an exemption or accommodation is approved. 


Americans with Disabilities Act (ADA) Statement

The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

 

Equal Employment Opportunity (EEO) Statement

The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.

 

Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.

 

Thank You

Your application was submitted successfully.

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