Public Administration Analyst - Clinical Research Coordinator - Paacrcuc20231213Ma#0012

Position: Public Administration Analyst - Clinical Research Coordinator

Location: Los Angeles, CA

Duration: 03+ Months with possible extension

Shift: 8:00 am - 5:00 pm

Job Summary:

• The Department of Medicine Clinical Trial Program is seeking a skilled 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. 
• Responsible for regulatory coordination of Clinical Research studies, preparation, submission and maintenance of regulatory files to fulfil research requirements.
• Additional responsibilities include regulatory compliance, patient recruitment and enrolment, 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 2 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.
• Demonstrated knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, etc
• 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, Clinical Research Associate, Clinical Research Regulatory