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Job Description

The mission of the California Heart Center is to integrate quality health care, clinical research, and continuing education to create an environment where advances are fostered for the immediate benefit of patients. The California Heart Center is committed to providing patients with the best medical care and customer service, and to continuously improve the quality of care and service throughout the organization. To learn more, please visit Cedars-Sinai California Heart Center.

Are you ready to be a part of breakthrough research?

The Clinical Research Coordinator II serves as the lead coordinator on an assigned portfolio of research studies, functioning independently to establish and coordinate logistics and processes for the conduct of research for the department. This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and Sponsor representatives to successfully implement research protocols, in compliance with all applicable regulatory requirements. 

Primary Duties and Responsibilities:

• Establishes and executes logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety.
• Coordinates administrative functions of research studies, including scheduling of patients for research visits, procedures, and labs, and completion and maintenance of consent forms, case report forms, SAE?s, and source documents.
• Responsible for screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and supporting the informed consent process.
• Responsible for accurate and timely data collection, documentation, entry, and reporting, including resolution of queries from sponsors or regulatory entities.
• Coordinates institutional, pharmaceutical, and internal audits, including facilitating third-party study monitoring and designs and implements needed corrective actions.
• 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.
• Responsible for timely submission of adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
• Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency as needed.
• Provides technical support for the preparation of grant proposals, publications, presentations, and special projects.
• Provides assistance with research project budget development, including identifying and classifying routine care vs. research-related care, and provides assistance with research participant research billing and reconciliation.
• Attend meetings and conferences related to research activities, including research staff meetings.
• Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested; Participate in training and education of new research personnel.

Qualifications

Education:

• An Associate Degree/College Diploma is required. Bachelor's degree preferred.

Licenses and Certifications:

• Basic Life Support (BLS) is required.
• Certification In Clinical Research (SoCRA or ACRP certification), Phlebotomy Certification (CA), and Certification as a Registered Medical Assistant are preferred.

Experience and Skills:

• Three (3) years of clinical research coordination or related experience is required.
• Maintains comprehensive knowledge of assigned research protocols to coordinate the compliant execution of assigned tasks in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements. 
• Ability to use software applications (MS Office Suite - Excel, Word, Outlook, PowerPoint) and operate technological devices (e.g., computer, laptop, tablet, smartphone, etc.). 
• Establishes effective working relationships with cross-functional team(s).
• Collaborates to solve problems and make decisions to achieve desired outcomes.
• Cultivates and maintains strong customer relationships and rapport with stakeholders and/or client groups.
• Identifies and responds appropriately to internal and external customer needs utilizing available resources.
• Represents the company with external constituents.

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About Cedars-Sinai Medical Center

Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competi...tive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.

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