We are a dynamic and forward-thinking clinical research organization dedicated to advancing medical knowledge and improving community health. We are looking for a passionate and dedicated Clinical Research Coordinator II to join our team. This role is perfect for someone seeking career growth, community engagement, and a challenging work environment.

The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.

Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

• Develop and maintain study-related documents, including intake forms and IRB submissions.
• Utilize REDCap for data collection and management.
• Collaborate with the research team to ensure study protocols are followed.
• Engage with the community to recruit and retain study participants.
• Handle multiple tasks simultaneously and work efficiently in ambiguous situations.
• Receive and act on feedback to continuously improve performance.
• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
• Schedules patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report
• Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
• Maintains accurate source documents related to all research procedures.
• Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Schedules and participates in monitoring and auditing activities.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.

Requirements:

• High School Diploma or GED required. Bachelors preferred.
• Minimum of 2 years of clinical research-related experience.
• Proficiency in REDCap and experience in creating intake forms.
• Familiarity with Institutional Review Board (IRB) processes.
• Excellent organizational and multitasking skills.
• Strong teamwork and communication abilities.
• Ability to work independently and manage time effectively.

What We Offer:

• Opportunities for professional growth and career advancement.
• A supportive and collaborative work environment.
• The chance to make a meaningful impact on community health.
• Comprehensive training and development programs.
• To learn more about this exciting work you can view: https://researchers.cedars-sinai.edu/Yelba.Castellon-Lopez/grants