Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Research Associate for a CONTRACT assignment with one of our premier INDUSTRY clients in Los Angeles, CA .
Responsibilities : 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 fulfill research requirements.
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.
Required Skills :
- A multi-tasked individual with a minimum 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, , 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
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