Sr. Clinical Research 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  We have an excellent opportunity for an Sr. Clinical Research Associate to join our team.

This is a hybrid position with 2 days a week on-site in our San Diego, Ca. office.

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.

• 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,…