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Vacancy : Clinical Regulatory Lead
Company Location : Remote
Position: Lead Research Regulatory SpecialistLocation: 100% remote (to go full time they can’t be in California or New Jersey – VUMC can’t work full time in those states)Start Date: ASAPEnd Date: 12 months contract with opportunity to go full time.JOB SUMMARYThe Lead Research Regulatory Specialist will prepare and submit protocols and supporting documents to regulatory bodies such as the Institutional Review Board (IRB). This role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Cancer Center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to insure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plan to improve quality or training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB.KEY RESPONSIBILITIESAdvanced knowledge and understanding of policies, procedures, and regulations governing human subject’s research and incorporates them in the conduct of research (e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations)Advanced knowledge and understanding of the management and implementation of clinical/translational research operationsAssesses for and implements process improvement initiatives within the department to assure research qualityRead and follow protocols and other study-related documentsJob Type: Full-timePay: $35.00 – $40.00 per hourBenefits:Dental insuranceHealth insuranceVision insuranceSchedule:8 hour shiftMonday to FridayEducation:Bachelor’s (Preferred)Experience:Clinical trials: 5 years (Required)regulatory: 3 years (Required)oncology: 1 year (Preferred)Work Location: Remote
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