Sr. CRA/Associate Clinical Project Manager

Details: Sr. CRA/Associate Clinical Project Manager About C3 Jian, Inc. C3 Jian is a well-capitalized, private, Los Angeles based biotechnology company advancing novel compounds that target unmet medical/dental needs related to oral healthcare. Position Objective: The Sr. CRA/ACPM will provide support to the Clinical Operations Department & report to the Senior Director of Clinical Operations (SDCO). The person will assist in the day-to-day activities involved in the conduct and monitoring of C3 Jian’s clinical trials. Responsibilities:  Assists the SDCO in the overall strategy, organization and implementation of clinical trials at designated study sites  Schedules appropriate on-site monitoring visits, performs subject/patient data audits  Reviews CRF data and verifies against medical/dental records; identifies discrepancies related to compliance with protocols, ensures completeness of CRFs in the defined timeframe for the study  Documents all interactions and communications regarding the study according to SOPs and GCP Guidelines  Cooperates with data management in the development of CRF design, completion guidelines, data management plans and other study specific documents  Assists the SDCO in the preparation of clinical study protocols, Investigator’s Brochures, IND annual reports and clinical study reports  In cooperation with the SDCO, prepares Clinical Monitoring Plans & Quality Plans  Prepares documents for site participation in a study (Informed Consent Form Templates, FDA 1572 forms, etc.)  Ensures regulatory compliance of investigators; reports compliance or ethical issues to the SDCO in a timely fashion  Initiates request for shipping of clinical product and tracking of product shipments  Prepares regulatory and clinical documentation for internal and site archives  Prepares project timelines for the investigational site(s)  Performs or assists in qualification visits to assess acceptability for the study  Performs or assists in site initiation visits to ensure adequate training of study staff  Monitors and tracks enrollment at participating investigative sites and overall progress of a clinical study  Assists in the preparation of study budgets, negotiates investigator budget, and anticipates need to amend existing budgets 
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