Clinical Research Coordinator II
1 week ago
Cedars-Sinai is seeking a highly skilled Clinical Research Coordinator II to join our team in the Smidt Heart Institute - Makkar Lab. As a key member of our research team, you will be responsible for coordinating clinical research studies, ensuring compliance with regulatory requirements, and providing exceptional patient care.
Key Responsibilities:
- Coordinate clinical research studies, including screening patients for protocol eligibility, presenting non-medical trial concepts, and participating in informed consent processes.
- Schedule patients for research visits and procedures, ensuring timely and accurate data collection.
- Collaborate with physicians and medical personnel to document patient information on Case Report Forms (CRFs).
- Maintain accurate source documents related to research procedures.
- Ensure compliance with federal and local regulations, including the Food and Drug Administration (FDA) and Institutional Review Board (IRB) guidelines.
- Participate in monitoring and auditing activities, ensuring data quality and study conduct.
- Compile and report study data, including protocol activity, accrual data, and workload information.
- Notify direct supervisors of concerns regarding data quality and study conduct.
- Work closely with regulatory coordinators and IRBs to submit adverse events, protocol deviations, and safety letters.
- May involve other regulatory duties, budgeting, and patient research billing and reconciliation.
Requirements:
- Bachelor's degree in a related field (strongly preferred).
- ACRP/SoCRA certification (or equivalent) preferred.
- Minimum two years of directly related experience.
About Us:
Cedars-Sinai is a leader in providing high-quality healthcare, encompassing primary care, specialized medicine, and research. Our commitment to innovation and excellence has earned us a reputation as a premier academic medical center.
About the Team:
Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with a team of over 2,100 physicians, 2,800 nurses, and thousands of other healthcare professionals and staff. We are dedicated to delivering exceptional patient care and advancing the field of medicine through research and education.
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