The successful candidate will be an experienced, self-motivated CTA/Sr CTA to support the day-to-day Clinical Operations functional activities associated with the execution of ongoing clinical trials outsourced to third party Vendors and CROs.
Job Duties include
- Assist the Clinical Team Leader (CTL) to prepare and maintain Trial Master Files (TMF) for multiple studies, ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents. Inform the CTL/Project Team on any outstanding document/s
- Develop knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of sample manifests
- Develop and maintain tracking spreadsheets with study level information to enable accurate and efficient supply of clinical drug product (IMP) and clinical supplies to Sites, Vendors and CROs
- Support financial oversight of clinical studies through invoice tracking and reconciliation for potential change orders
- Day-to-day contact with counterpart at outside Vendor, CRO and/or trial site; daily review and identification of potential issues or problems and communicate/escalate to CTL/Project Team
- Tracking of patient and recruitment status using applicable spreadsheets and web portal tools
- May assist in the review of key study documents (e.g., Protocol, ICF, study plans, eCRF)
- Effective time management and organizational skills
- Attention to detail and accuracy in work
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- General working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Computer skills, including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint
- Demonstrates ability to manage components of clinical trials with general guidance from CTL
- 3-6 years of Clinical Operations experience and a 2-year degree or 1-3 years Clinical Operations experience and a 4-year degree (BS or BA)
Xencor Inc. is an innovative biotechnology company headquartered in the Los Angeles area near Pasadena and with an office in San Diego. We recently completed a successful initial public offering (IPO). We use our pioneering XmAb® technology to develop better biotherapeutics — antibodies that target new biological mechanisms and are more potent, safer and longer lasting — to improve patient outcomes and quality of life.
In addition to generating a pipeline of novel drug candidates, our XmAb® technology is being validated through our collaborative agreements with leading biopharmaceutical companies including Amgen, Morphosys, Merck, 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, a passion for innovation and a willingness to take risks.
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 coworkers 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 and benefits package.