Sr. Clinical Research Associate

Clinical Operations · San Diego, California
Department Clinical Operations
Employment Type Full Time
Minimum Experience Mid-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 cytokines with improved function, with the goal of improving patient outcomes and quality of life. We have an excellent opportunity for a Sr. Clinical Research Associate 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.


This position will by a hybrid role with 2 days on-site in our San Diego site.

 

Summary:

Responsible for interfacing with investigative sites to monitor conduct and assess progress of clinical research studies to ensure compliance with protocol(s) and all applicable procedures, regulations, and guidelines.

 

Job Duties Include:

  • Responsible for the completeness of documents managed in the electronic Trial Master Files (TMF); performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines
  • Conducts all operational responsibilities in compliance with applicable Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines
  • Involved in the independent completion of activities across multiple clinical studies, ensuring that the safety of the subjects and integrity and validity of the study data are maintained as needed
  • Develops and reviews regulatory documentation to support study start up activities, including ensuring all site supplies are available on site for site initiation visits
  • Acts as primary liaison for assigned study sites, CROs and Vendors to convey project information, answer questions and resolve issues in accordance with the CTM escalation pathway
  • Attends prepares and presents materials for Investigator Meetings and study-specific training for assigned trials when needed
  • Ensures all regulatory documents and study supplies are maintained during the lifecycle of assigned clinical trials in collaboration with the CTM
  • Conducts and oversees all phases of study monitoring (PSV, SIV, IMV, and COV), either independently or jointly with CRO partner
  • Oversees subject recruitment and treatment status remotely through IxRS and EDC systems and direct communication with sites in order to update detailed tracking sheets daily
  • Oversees various study related tracking sheets to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB, etc.) and follows up to collect outstanding documents
  • Maintains current understanding of assigned clinical trial protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned trials
  • Contributes to  the study budget process by managing and reconciling invoices  for 3rd party CROs, Vendors, Consultants and Clinical Sites
  • Partners with the CTM for overall project management of trials including preparing meeting agenda, minutes and action items
  • Identifies new approaches to resolve problems and mitigate risks
  • Serves as mentor for junior CRAs and CTAs and those new to the company and/or clinical trial management
  • Adheres to all department and company-wide policies regarding conduct, performance and procedures
  • Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities
  • Performs other duties as required.

 


Education/Experience/Skills:

Position minimally requires a high school diploma/GED with 9 years of related experience; a Bachelor’s degree with 5 years related experience is preferredAt least 3 years of direct experience with clinical site management, CRO/Vendor management and logistical execution of clinical trials is required. Experience working in a small company in the biotech or pharmaceutical industry preferred. Prior people and/or team management experience, directly or indirectly, and experience with SmartSheet and Veeva Vault eTMF system also preferred.

 

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

Position also requires:

  • Excellent 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
  • Strong understanding of clinical trials, drug development, Phase I through Phase III
  • Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint
  • Strong working knowledge of ICH GCP as relates to clinical trial management
  • Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices.  Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.

 



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

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