The Director, Quality Control directs the development, planning, implementation, and maintenance of Quality methods, processes, and operations for new or existing products and/or technologies. The QC group is comprised of the following functions: Analytical Chemistry, Microbiology, Environmental Monitoring, QC inspection and support. This individual will provide strategic and tactical leadership to the Quality organization ensuring the execution of responsibilities within the Quality System.This position manages people and is responsible for all work completed within the QC group for pharmaceutical and medical device products.
Reporting to the Clinical Project Manager, the Senior CRA will assist and provide support to the members of the clinical trial team in order to facilitate the clinical trial processes including execution of clinical trials. The Senior CRA is responsible for designing, implementing and maintaining clinical trials, and he/she will write protocols, case report forms and consent forms, recruit and select investigators and ensure good clinical practices are followed.
This is an exciting opportunity for an energetic and organized CRA with at least 2 years monitoring experience to grow their clinical career to a CRA II. In this position you will assist and provide support to the members of the clinical trial team in order to facilitate the clinical trial processes including execution of clinical trials. The CRA II will assist with the following: designing, implementing and maintaining clinical trials; writing protocols, case report forms and consent forms; and recruiting and selecting investigators and ensuring good clinical practices are followed.
The Clinical Project Manager is responsible for managing clinical trials from initiation to completion through leading the development of study protocols, case report forms and clinical reports, as well as overseeing site monitoring visits and interfacing with site staff, Clinical Research Organizations (CRO), and other company representatives. This position is also responsible for supporting clinical trials as required.