Public Administration Analyst - PAA24-03856

Location

Santa Monica, CA | United States

Job description

Title: Public Administration Analyst
Location: Santa Monica, CA
Duration: 12-week contract with the possibility of permanent hire
Shift: Monday-Friday, 8:00-5:00

REQUIRED EXP: Min 2 yrs exp in a clinical research coordinator role, College Degree, exp with IRB procedures, recruiting and enrolment, completing CRFs

Job Duties:

• 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, and protocol information dissemination to healthcare professionals, patients and their family members.
• Work may be assigned by Senior Management, and assignments may be changed on an as-needed basis to ensure that studies and patient care needs are handled appropriately and promptly. Travel to other locations may be required.

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

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