$200K — $250K *
The Regulatory and Clinical Quality Coordinator will report directly to the VP of Regulatory Affairs and Quality Systems and will provide support to the regulatory and quality group in the ContraFect organization. We are looking for a detail-oriented professional to join our Regulatory and Quality team as a Regulatory and Clinical Quality Coordinator.
The position will provide support to the Regulatory and Quality department that includes, scheduling departmental meetings, processing expense reports, and travel planning. Clinical quality activities will include working with the Clinical Development Operations team to track and file Sponsor eTMF records, coordinate new and maintenance of SOPs, schedule training, and maintain employee training records. Regulatory support will include providing assistance in preparing and coordinating IND amendments for FDA submission by liasing with external publishing vendor, and maintaining and tracking regulatory archives.
University degree or equivalent in health sciences, nursing, pharmacy or related field preferred or equivalent experience.
Minimum of 5 years of work experience with 2 years experience working in regulated environment, preferably pharmaceutical industry. Demonstrate a working knowledge of internal SOP's, FDA/lCH guidelines to GCP's and regulatory compliance.
Knowledge of and direct experience with content of Trial Master File and prior regulatory experience desirable. Fundamental knowledge of the conduct of clinical trials is preferred.
Competent in use of MS Word, Excel, and PowerPoint, and Adobe Acrobat
Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. Must be able to work independently as part of virtual team.
Valid through: 4/15/2021
$140K — $180K + $15K bonus