Clinical Research Associate I - Butte Lab - Department of Neurosurgery (Per Diem)

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.

We invite you to consider this phenomenal opportunity!

Dr. Pramod Butte, Ph.D. is looking for a Clinical Research Associate I to join a diverse team!

The primary focus of the Butte Laboratory is translational research in the field of bio-photonics. The Butte Lab is developing novel intra-operative imaging/visualization technologies to aid surgeons in achieving near-complete tumor excision. To learn more about the Butte Lab, please visit this website.

Serving as a Clinical Research Associate at Cedars-Sinai, you will assist in the effort in validating the clinical trial of groundbreaking medical imaging systems. The job will provide an outstanding opportunity to work with a multidisciplinary team involving optical engineers, mechanical engineers, electrical engineers, biomedical engineers as well as surgeons, pathologists, and other medical personnel. You will be involved in the development and possible commercialization of a novel medical device technology. Interest or experience in a start-up environment with an entrepreneurial spirit is highly desired. The position will provide experience as a part of a highly focused team on a broad array of technologies. In addition, the position will also offer experience with other technicians, with clinical trials, collecting clinical data, and play a crucial part in developing clinical protocols. The position will provide opportunity to work on medical technology with far reaching and immediate impact on patients’ lives.

The CRA I member will work 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, provides limited patient contact as needed for study, and assists with study budget and patient research billing. This role will follow all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Primary Job Duties and Responsibilities:

• Schedules patients for research visits and research procedures.
• 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) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• 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.
• Participates in required training and education programs.

Department-Specific Duties and Responsibilities:

• Obtains patient consent, if authorized, to participate in clinical study.
• Engages with OR staff to ensure informed, accurate, and timely transport, scanning, and processing of specimens in the context of the clinical study.
• Works with, handle, and process fresh and fixated specimens per outlined protocol Perform scanning of specimens using clinical prototypical imaging device(s).
• Performs transport, set-up, tear-down of clinical equipment used in clinical study.

Education:

• High School Diploma or GED, required.

Experience and Skills:

• Understanding of general research objectives.
• Experience in a clinical research setting is highly preferred.