The Smidt Heart Institute reflects Cedars-Sinai\'s steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.
Join our team and use your skill with an organization known nationally for excellence in research!
Job Summary:
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study.This role evaluates and abstracts research data and ensures compliance with protocol and research objectives.Position is responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Job Duties and Responsibilities:
Works with a Clinical Research Coordinator, Research ProgramAdministrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinical research data from source documents.
Ensures compliance with protocol and overall clinical research objectives.
Completes Case Report Forms (CRFs).
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets and patient research billing as needed
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
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 (Google Cloud Platform) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Education:
High School diploma/GED required.
BA/BS degree in Science, Sociology or related degree preferred.
Experience:
Understanding of general research objectives.
1 year of clinical research related experience preferred.
- Excellent language skills and understanding of Grants, Manuscript, and Abstract guidelines.
- Strong verbal and writing ability as well as communication, computer, organization, personnel and time-management skills.
- Proficiency in Word, PowerPoint and Excel.
- Ability to work independently, set priorities, and handle multiple tasks requiring attention to detail.
- Previous experience in research environment preferred.
Physical Demands:
- Able to perform moderate lifting.
- Able to sit, stand and walk for prolonged periods of time
- Able to read papers and online documents.
- Able to operate standard office equipment
- Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
