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Clinical Trials AssistantCompany Xencor
Location San Diego, CA 92130
Update 8 Day ago
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 three programs currently in clinical testing with one more expected to start clinical testing in 2017 and have an excellent opportunity for a Clinical Trials Assistant/Sr CTA 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 ten in clinical testing by Xencor or our partners, our XmAb ® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, 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 and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
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.
We seek a/an Clinical Trials Assistant/Sr CTA to
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
Develops 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 communicates/escalates 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 (eg, Protocol, ICF, study plans, eCRF)
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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)
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.
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 to firstname.lastname@example.org . For further information about Xencor, please visit our website at www.xencor.com EOE