CON-Clinical Trials Associate

CON Clinical Trials Associate

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit [click to reveal website link]www.xencor.com. We have an excellent opportunity for a Contract/Temporary Clinical Trials Associate to join our San Diego team.

This position will be based out of the San Diego, CA. office with minimum of two days a week on-site.

This is a temporary/contract position

Position Summary:

On a contract basis, responsible for assisting Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) by supporting the day-to-day activities of assigned trials.

Primary Responsibilities:

• Assists the CTM or CRA to prepare and maintain Trial Master Files (TMF) for assigned trials, ensuring tracking of ICH-GCP and/or FDA 21CFR essential study documents
• May perform reconciliation and/or tracking of biological sample manifests
• Maintains tracking spreadsheets with study level information to enable accurate and efficient supply of clinical drug product and clinical supplies to Sites, Vendors and CROs
• Tracks patient and recruitment status using applicable spreadsheets and web portal tools
• Maintains day-to-day contact with counterparts at external vendor(s), i.e. CRO and/or investigator trial site (as appropriate) and other Sponsor cross-functional groups, including TMF Operations
• May assist in the review of key study documents (e.g., Protocol, ICF, study plans, pharmacy manual, laboratory manual, eCRF)
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Performs other duties as required.

Education/Experience/Skills:

Position minimally requires a high school diploma/GED with at least 3 years relevant experience; Bachelor's degree in a life sciences or related field preferred. Prior experience working in biotech or pharmaceutical industry required. Prior experience working at a CRO in a similar role may be considered.

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
• Veeva TMF experience required
• Strong oral and written communication skills
• 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.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Expected Base Salary Range: $35.00/hr. - 40.00/hr.

The actual salary will be based on the selected candidate's qualifications, including skills, competencies, education and experience.

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 [click to reveal email address]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.