Clinical Research Associate I (Per Diem)
Cedars-Sinai
About the Role
The Clinical Research Associate I works under the supervision of Principal Investigator and Research Scientist Dr. Raj Makkar and under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff. This role assists in tasks supporting the coordination and implementation of noncomplex research studies, supporting research objectives through data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance.
Key Responsibilities
- Works with a Clinical Research Coordinator, Research Program Administrator, 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) provided by 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), including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
- Assists with clinical trial budgets.
- Assists with patient research billing.
- Assists with prescreening of potential research participants for various clinical trials.
- 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 (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
Qualifications
- Education:
- High School Diploma/GED is required.
- Bachelor's degree in Science, Sociology, or a related field preferred.
- Experience and Skills:
- One (1) year of clinical research related experience is preferred.