We invite you to consider this great opportunity!

When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.

Dr. Lisa Bateman, MD is seeking a highly motivated Clinical Research Associate II to join her dynamic team!

Dr. Bateman is a Professor of Neurology and Director of the Cedars-Sinai Health System Surgical Epilepsy Program. This program offers the latest tests and treatments to help people with all forms of epilepsy get relief. We are a Level 4 epilepsy center, and our experts provide top-tier care for those dealing with epilepsy.

The Clinical Research Associate II will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for external sponsors. This role evaluates and abstracts research data, and ensures compliance with protocol and research objectives. This position is responsible for completing case report forms (CRFs), entering clinical research data, and assist with regulatory submissions to the Institutional Review Board (IRB). The incumbent assists with study budget and research participant billing. The CRA II may coordinate activities, training, and education for other CRA members. This role follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

*This position is hybrid*

Primary Job Duties and Responsibilities:

• Provides supervised contact with research participants or contact for long term follow-up research participants only.
• Enters data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• 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.
• Schedules research participants for research visits and research procedures.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• May participate in the development of Investigator initiated trials for Investigational New Drug applications and/or Device applications.
• Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
• Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives.

Department-Specific Duties and Responsibilities:

• Transportation of research medications.
• Performs study related assessments and questionnaires.
• Assists with prescreening of research participants for various clinical trials
• Attends research meetings and monthly conference calls with sponsors for study updates.
• Maintains organized paper and electronic research files.
• Performs all data collection and data entry tasks for department clinical trials.
• Assists with preparing manuscripts, letters, and other research documents as needed.
• Responds to sponsor’ inquiries regarding protocol start-up activities and recruitment.
• Performs literature reviews.

Qualifications:

• High School Diploma/GED is required.
• 1 year of clinical research related experience is required.
• Bilingual in Spanish.