To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03069

About our client Our client, a privately held pharmaceutical company, is focused on the development and commercialization of innovative therapeutics for the treatment of severe ocular diseases and conditions. Based in California, the company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Senior Clinical Research Associate Northern California (Central Bay) Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist the CRO Project Manager 2) Review CRFs, monitoring conventions, study manuals and monitoring reports generated by CRO 3) Establish/monitor SAE process with CRO and review SAE reports 4) Review CRO data specs and serve as a primary contact for data issues raised by CRO data managers 5) Establish/monitor processes for drug shipments, storage, accountability and returns 6) Attend CRO Team meetings 7) Coordinate preparation/updates of Annual Reports and Investigator Brochures 8) Periodic co-monitoring with CRO CRAs 9) Support other vendors (e.g. central lab, IVRS, drug depot, etc.) Requirements 1) RN or BS in Biological Sciences or any related/equivalent field preferred 2) Minimum 3 years of monitoring experience 3) Minimum 3 years of clinical research experience 4) Knowledge of FDA regulatory guidelines 5) Familiarity with medical and pharmaceutical industry, terminology and practices 6) Proficiency with MS Word, MS Project and Excel