Sr. Public Administration Analyst - Clinical Research

Ampcus, Inc
United States, California, Los Angeles
Nov 09, 2024
Job Duties The Department of Medicine Clinical Trial Program is seeking a skilled Senior Clinical Research Associate to oversee, manage and participate in research activities. Providing oversight of clinical research sites compliance with ICH/Good Clinical Practices (GCP), governing SOPs (standard operating procedures) and clinical study protocols. This includes responsibility for research assessment and patient intervention under the supervision of the Principal Investigator. Additional responsibilities include regulatory compliance, patient recruitment and enrollment, data collection, research chart documentation, quality assurance, report preparation, protocol information dissemination to health care professionals, patients and their family members. Work may be assigned by Senior Management, and assignments may be changed on an as-needed basis in order to ensure that studies and patient care needs are handled appropriately and in a timely manner. Travel to other locations may be required. Qualifications A multi-tasked individual with a minimum 5 years of experience in a clinical research coordinator role. College degree in medicine, science, health, or equivalent. Performs management of research activities to ensure the collection of accurate clinical data within given timeline. Knowledge of ICG GCP guidelines and expertise to review, evaluate medical data and all applicable local laws and regulations. Experience in selection and management of vendors/CROs (Central Lab, IVRS, EDC) Track progress of clinical studies with regard to budget, study milestones, and deadlines. Recruiting & enrolment of patients who meet eligibility criteria, scheduling, completing CRFs. Able to solve complex problems, prioritize multiple tasks, plan proactively and accomplish goals within project in a dynamic team environment Participate in study audits, as applicable Experience: Study Coordinator, Clinical Manager, Clinical Research Associate, Senior Clinical Research Associate Skills: Attention to detail, analytical, organized, interpersonal communication, multitasking. Location: Currently on-campus (Westwood, CA) and travel as needed. Schedule: Monday-Friday. 8 am - 5 pm.