Job Description

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!

As a Clinical Research Associate I, you will work under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of non-complex research studies. The incumbent will support objectives of research studies through non-complex tasks such as data collection, pre-screening and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.

Primary Job Duties and Responsibilities:

• Collects, evaluates and/or abstracts clinical research data.
• May assist in designing forms for data collection/abstraction.
• Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Completes Case Report Forms (CRFs).
• Schedules research participants for research visits and research procedures.
• Provides supervised patient contact or independent patient contact for long term follow-up patients only.
• Assists supervising staff 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 and patient research billing.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with protocol and overall clinical research objectives.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• May serve as one point of contact for external sponsors for select trials.
• May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.

Department-Specific Duties:

• Maintains CITI certification.
• Compiles, analyzes, and presents work at internal meetings and conferences.
• Performs data searches and other related administrative tasks.
• Assists with research protocol writing and development.
• Assists with prescreening of research participants for various clinical trials.
• Attends research meetings and monthly conference calls with sponsors.
• Maintains organized paper and electronic research files.
• Performs all data collection and data entry tasks for departmental clinical studies.
• Assists with preparing manuscripts, letters, and other research documents as needed.
• Coordinates study related activities and subject recruitment with Laboratory Staff.

Qualifications

Education:

• High School Diploma/GED is required.
• Bachelor's degree in Science, Sociology, or related degree is preferred.

Experience:

• One year of clinical research related experience is preferred.