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.

The Clinical Research Associate II will assist in the effort of validating the clinical trial of cutting-edge medical imaging systems. The job will provide a unique 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. The CRA II 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 an opportunity to work on medical technology with far reaching and immediate impact on patients’ lives.

The Clinical Research Associate II works 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 the external sponsors. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. The CRA II is responsible for completing case report forms, entering clinical research data, and assists with regulatory submissions to the IRB. The incumbent provides limited contact with research participants as needed for study and may assist with study budget and research participant billing. In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Primary Duties and Responsibilities:

• 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 contact with research participants or contact for long term follow-up research participants 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.
• Schedules research participants 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.
• Serves as the point of contact for external sponsors for select trials.
• May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications.
• May be involved in training and education of other Clinical Research Associates.
• Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives.
• Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.

Education:

• High School Diploma or G.E.D. is required.
• BA/BS degree or Master of Science degree is preferred.

Licenses:

• ACRP/SoCRA (or equivalent) certification preferred.

Experience:

• One year of directly related experience is required. Two years of relevant experience is highly preferred.
• Ability to work in the clinical environment is essential (the candidate will be involved in data collection from human subject in the operating room environment).
• Familiarity of working in a highly regulated environment is a plus.
• Ability to use Excel (e.g. formulas) preferred.

Physical Demands:

Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to stand for at least 4 hours and push mobile imaging platform. 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.