Clinical Research Associate I - Pulmonary Research Program/Lung Institute

at  CedarsSinai

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.

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.

ABOUT US

Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow’s health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.

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).
• 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.
• 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 and 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:

• Assists with prescreening of potential research participants for various clinical trials.
• Maintains organized paper and electronic research files.
• Assists with preparing manuscripts, letters, and other research documents as needed.
• Performs literature reviews.