Clinical Research Coordinator I - CA Heart Foundation

Cedars-Sinai

Posted 3 months ago

Full Time

Los Angeles, California

In Person

Smart Summary

Responsibilities

The Clinical Research Coordinator independently manages study coordination, including patient screening, informed consent, and data collection. They ensure compliance with federal and local regulations while maintaining accurate source documents and reporting study progress.

Qualifications

This Clinical Research Coordinator I position at the California Heart Center requires someone to independently coordinate studies, screen candidates for eligibility, and ensure accurate data collection and reporting. The role involves presenting trial concepts, participating in the informed consent process, and maintaining compliance with regulatory agencies. Ideal candidates should possess strong organizational and communication skills.

Job Description

Grow your career at Cedars-Sinai!

The California Heart Center is an affiliate of the Cedars-Sinai Heart Institute, located in Beverly Hills, California, 90211. We offer the full spectrum of cardiology care, including, Cardiac Evaluation/Adult Cardiology, Heart Failure Management, Interventional Cardiology, Nuclear Cardiology and Echocardiography. 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 developed for the immediate benefit of patients.

In addition to our private cardiology practice, CA Heart Center physicians are active clinical research investigators and hold leadership positions in heart failure, heart transplantation, and mechanical cardiac assist devices and heart failure/transplant clinical research at the Cedars-Sinai Heart Institute (CSHI). In addition to its highly-regarded cardiology program, CSHI is doing groundbreaking work in other important cardiovascular areas, including cardiac stem cell transplants and non-surgical heart valve replacements. In partnership with CSHI, the California Heart Center offers a multi-disciplinary and integrated approach to the care of patients with heart disease. To learn more, please visit Cedars-Sinai California Heart Center.

Why work here?

Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.

Are you ready to be a part of breakthrough research?

The Clinical Research Coordinator I works independently to coordinate studies and screen candidates to determine protocol eligibility. They present non-medical trial concepts and details and participate in the informed consent process. Ensures source documents, data collection, documentation, entry, and reporting are accurate and completed promptly, including responding to sponsor queries without delay. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies such as the Food and Drug Administration (FDA) and the local Institutional Review Board (IRB). 

Primary Duties & Responsibilities:

  • Independent study coordination including assessing 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 gathering, recording, entry, and reporting of data 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.
  • Notifies direct supervisor about concerns regarding data quality and study conduct.
  • Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
  • May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
  • Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
  • Maintains research practices using Good Clinical Practice (GCP) guidelines.
  • Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
  • Participates in required training and education programs.

Cedars-Sinai

Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service. Today, Cedars-Sinai is widely known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai receives consistent recognition for our excellence. Our awards include; being named one of America’s Best Hospitals by U.S. News & World Report, receiving the National Research Corporation’s Consumer Choice Award 19 years in a row for providing the highest-quality medical care in Los Angeles, achieving the longest-running Magnet designation for nursing excellence in California, and being recognized as The Advisory Board Company’s 2017 Workplace of the Year, an award Cedars-Sinai has won three years in a row. This annual award recognizes hospitals and health systems nationwide that have outstanding levels of employee engagement. Cedars-Sinai is a leader in the clinical care and research of heart disease, cancer and brain disorders, among other areas. Pioneering research achievements include using cardiac stem cells to repair damaged hearts, developing minimally invasive surgical techniques and discovering new types of drugs to target cancer more precisely. Cedars-Sinai also impacts the future of healthcare through education programs that encompass everything from highly competitive medical residency and fellowship programs to a biomedical science and translational medicine PhD program, advanced training for nurses and educational opportunities for allied health professionals. Most notably, Cedars-Sinai demonstrates a longstanding commitment to strengthening the Los Angeles community through wide-ranging programs that improve the health of its most vulnerable residents.
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