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Clinical Research Specialist I
2 months ago
About Cedars-Sinai: The Smidt Heart Institute exemplifies Cedars-Sinai's unwavering commitment to heart disease treatment and research innovation, providing patients with access to exceptional care.
Our team of cardiologists, cardiac surgeons, and specialized care groups address a comprehensive range of heart diseases and disorders, while our researchers continue to push the boundaries of medical science with pioneering, life-saving studies.
From genetic counseling and targeted therapies to an expanding selection of minimally invasive procedures, Cedars-Sinai remains at the cutting edge of technology, innovation, and discovery, enhancing patient outcomes.
Position Overview: The Clinical Research Specialist I collaborates closely with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to facilitate and/or execute clinical studies.
This role involves evaluating and abstracting research data, ensuring adherence to study protocols and objectives. Responsibilities include completing case report forms, entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). Limited patient interaction may be required for study purposes, along with support for study budgets and patient research billing.
Key Responsibilities:
- Evaluate and abstract clinical research data from primary source documents.
- Ensure compliance with study protocols and overarching clinical research goals.
- Input clinical research data into Electronic Data Capture (EDC) systems provided by sponsors.
- Assist with regulatory submissions to the IRB, including reporting Adverse Events, Serious Adverse Events, and Safety Letters in line with local and federal regulations.
- Support the management of clinical trial budgets.
- Assist with patient research billing processes.
- Schedule patient appointments for research visits and procedures.
- Handle sample preparation, shipping, and maintenance of study supplies and kits.
- Ensure compliance with all relevant federal and local regulations, including those from the Food and Drug Administration (FDA) and local IRB.
- Maintain research practices in accordance with Good Clinical Practice (GCP) guidelines.
- Participate in necessary training and educational programs.
Qualifications:
A Bachelor's Degree in Science, Sociology, or a related field is preferred, along with a minimum of one year of relevant clinical research experience.
Cedars-Sinai is recognized as a leader in delivering high-quality healthcare, encompassing primary care, specialized medicine, and research.
Since its inception, Cedars-Sinai has adapted to meet the diverse needs of the community, setting benchmarks in quality patient care, research, education, and community service.
Today, Cedars-Sinai is renowned for its national leadership in transforming healthcare for the benefit of patients, impacting the future of healthcare through innovative treatment approaches and the education of future health professionals.
Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with a robust team of healthcare professionals dedicated to providing exceptional care.
Work Environment: This position offers an opportunity to thrive in a dynamic setting that prioritizes the highest level of care for patients in need.
