Job Description
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.
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.
About the Team Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
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