Sr. Clinical Research Associate

Sr. Clinical Research Associate

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

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.

Primary Responsibilities:

• 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 preferred. At 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.

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 demonstrate competencies applicable for job based on Xencor's Leadership Competency Model
• 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.
• Familiarity with AI tools and the ability to use them in a compliant and responsible manner, including validating outputs, mitigating risks, actively reinforcing responsible use across teams, and ensuring strict adherence to company policies and regulatory requirements.
• Ability to demonstrate competencies applicable for job based on Xencor's Leadership Competency Model

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

Expected Base Salary Range: $125,800 - $167,800

The actual salary will be based on the selected candidate's qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.