Clinical Research Specialist I
5 days ago
Be a part of pioneering research that shapes the future of healthcare.
The field of regenerative medicine is rapidly evolving, focusing on restoring functionality in damaged or aging tissues through innovative techniques such as revitalizing existing cells or introducing new ones. At Cedars-Sinai, our dedicated team is transforming stem cells into therapeutic solutions for a variety of common diseases and conditions. We are also committed to disease prevention and sharing our knowledge with students and researchers globally.
Are you prepared to contribute to groundbreaking research?
The Clinical Research Specialist I will collaborate 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 while 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. Compliance with all federal, local, FDA, IRB, and HIPAA regulations regarding the study and patient care is essential.
Key Responsibilities:
- Collaborate with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to facilitate and implement clinical studies.
- Evaluate and abstract clinical research data from original documents.
- Ensure adherence to study protocols and overall clinical research objectives.
- Complete Case Report Forms (CRFs) accurately.
- Input clinical research data into Electronic Data Capture (EDC) systems provided by sponsors.
- Provide supervised patient contact or contact for long-term follow-up patients as necessary.
- Assist with regulatory submissions to the Institutional Review Board (IRB), including reporting Adverse Events and Safety Letters in accordance with local and federal guidelines.
- Support clinical trial budgeting processes.
- Assist with patient research billing procedures.
- Schedule patients for research visits and procedures.
- Manage sample preparation, shipping, and maintenance of study supplies and kits.
- Ensure compliance with all relevant federal and local agencies, including the Food and Drug Administration (FDA) and local Institutional Review Board.
- Uphold research practices in line with Good Clinical Practice (GCP) guidelines.
- Maintain strict patient confidentiality in accordance with HIPAA regulations and applicable laws.
- Participate in mandatory training and educational programs.
Qualifications
Education:
- A High School Diploma is required; a bachelor's degree in a relevant field such as Science or Sociology is preferred.
Experience and Skills:
- Familiarity with general clinical research objectives; one (1) year of clinical research experience is preferred.
- Ability to interpret and apply knowledge of State, Federal, and Agency standards to ensure regulatory compliance.
- Proficient computer skills, including Microsoft Word and Excel, along with the ability to operate standard office equipment are required.
About Cedars-Sinai
Cedars-Sinai is a prominent provider of high-quality healthcare, encompassing primary care, specialized medicine, and research initiatives. Established in 1902, Cedars-Sinai has continually adapted to meet the diverse needs of the community, setting benchmarks in quality patient care, research, education, and community service. Today, Cedars-Sinai is recognized for its leadership in transforming healthcare for the benefit of patients and is dedicated to developing innovative treatment approaches while educating future health professionals.
About the Research TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the United States, featuring 886 licensed beds, 2,100 physicians, 2,800 nurses, and thousands of other healthcare professionals and staff. This is an ideal environment for those seeking to work in a dynamic setting that provides the highest level of care to individuals in need.
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