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SUPERVISOR REGULATORY CLINICAL RESEARCH - HIRE
Newport Beach, CA The Clinical Research Regulatory Supervisor assists in overseeing clinical research regulatory operate on activities. Is responsible for conducting clinical research to industry standards and best practices. Assists with ensuring proposed projects meet the mission and vision of **MEMBERS ONLY**SIGN UP NOW*** and all clinical research stakeholders. Assists the clinical research teams (physicians, nurses, etc.) facilitate the study start-up approval process and maintain documentation of regulatory compliance throughout a clinical research study's duration for studies involving human participants. Ensures all research studies are compliant with regulations and maintains accurate, up-to-date, regulatory files. Is the central resource for staff . Manage the day-to-day clinical research regulatory operations ensuring regulatory responsibilities are completed correctly and completely. Interact daily with the team to ensure Studycompliance. Oversee the process of informed consent to include institutional language. Works with legal/sponsors to ensure CTA language is consistent with consent. Designs, implements, and manages a system for organizing, planning workflow related to all research regulatory study activities including developing organizational forms and tools to conduct the study accurately and in compliance with Good Clinical Practice, to facilitate study completion and compliance. Is up to date on current federal, state, and local regulations and communicates changes to the study team. Works closely with Director Clinical Research - Finance & Regulatory. Provides institutional authorization for new submissions with IRB. Tracks each protocol through theIRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease the delay in the approval process. Registers & maintains clinical trials on the clinicaltrials.gov website for applicable studies and works with sponsors to include **MEMBERS ONLY**SIGN UP NOW***. Maintains and updates the study management portion of the department's clinical trial management system. Maintains Institution's Federal Wide Assurance to ensure **MEMBERS ONLY**SIGN UP NOW*** remains current and compliant. Assists in the development, writing, and maintenance of SOPs including work instructions, forms, and templates. Other duties as assigned. Education and Experience: Required: *High School graduate or equivalent. *Bachelor's degree or five plus (5 ) years of clinical research experience. *Excellent communication and organizational skills are required. *Understands and keeps current with FDA and Medicare regulations and/or third-party insurance guidelines applicable to clinical trials required. *Is knowledgeable of Clinical Research study protocols and internal SOPs required. |
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