Sr. Clinical Research Associate (Sr. CRA/In-house)
Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including five programs currently in clinical testing with three more expected to start clinical testing by 1Q2019 and have an excellent opportunity for a Head of Investor Relations & Corporate Communications to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting – with the goal of improving patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with eleven in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.
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.
We have multiple openings for a Senior Clinical Research Associate (Sr. CRA / in-house) to
Job Duties include:
- Responsible for the maintenance of the electronic Trial Master Files (TMF). Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with Xencor SOPs, GCP and ICH Guidelines
- Responsible to develop and review 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 Investigator Meetings and study-specific training for assigned trials
- Ensures all regulatory documents and study supplies are maintained during the lifecycle of assigned clinical trials in collaboration with the CTM
- Monitors subject recruitment and treatment status remotely through IxRS and EDC systems and direct communication with sites in order to update detailed tracking sheets daily
- Preparation and review of 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 responsible for the follow up to collect outstanding documents
- Understanding of assigned clinical trial protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned trials
- Participate in the study budget process and invoice tracking for 3rd party CROs, Vendors, Consultants and Clinical Sites
- In partnership with the CTM, may prepare meeting agenda, minutes and action items
- Taking the initiative and identifying new approaches to resolve problems and mitigate risks
- Serves as mentor for junior CRAs and CTAs and those new to the company and/or trial
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
- 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
- Understanding of clinical trials, drug development, Phase I through Phase III
- Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint
- Experience with SmartSheet (desired)
- Experience with Veeva Vault eTMF system (strongly preferred)
- Solid working knowledge of ICH GCP as relates to clinical trial management
- BS/BA degree in Life Science (strongly preferred)
- Typically requires a minimum of 5-8 years of direct expertise with clinical site management, CRO/Vendor management and logistical execution of clinical trials required
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume. For further information about Xencor, please visit our website at www.xencor.com EOE