Do you have a passion for the highest clinical quality and patient happiness? Would you like to use your expertise with an organization known nationally for excellence in cancer treatment, research and education? We would be happy to hear from you! Please consider the following exciting opportunity with one of the most outstanding and dynamic places to work in the medical field as your next career move.
The Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory bodies such as the IRB, etc. The role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trials.
Other duties include, representing the Medical Center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to ensure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, and training and education of personnel. May participate in centralized activities of the department or institution. Ensures compliance with all federal and local agencies including the FDA and IRB.
Primary Duties and Responsibilities
Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory
documents for the research studies are up-to-date.
Attends weekly research team meetings and updates staff and investigators on the status of regulatory
submission and amendments.
May provide training and education of other personnel.
May participate in centralized activities of the department or institution.
BA/BS Degree required
Three (3) years minimum of directly related experience.
Licenses: Specialty research certification preferred.
Working Title: Regulatory Coordinator II - Neurology
Business Entity: Academic / Research
City: Los Angeles
Job Category: Family & Function, Academic / Research
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.