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Location

Beverly Hills, CA | United States

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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!

The Clinical Research Associate I 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. The incumbent is responsible for completing case report forms, entering clinical research data, and assists with regulatory submissions to the IRB. The CRA I member provides limited patient contact as needed for study and assists with study budget and patient research billing. The incumbent ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Primary Job Duties and Responsibilities:

• 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.
• Works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters following local and federal guidelines.
• Assists with clinical trial budgets and patient research billing.
• Schedules patients 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 including CSMC phlebotomy-specific clinical oversight which encompasses initial training, monthly assessments, six-month assessments, and annual assessments.
• Performs phlebotomy services according to CSMC policies and procedures.
• Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated
• Identifies patients and patient specimens by strict adherence to established procedures; labels samples accurately and completely.
• Reports test results to appropriate individuals and exercises professional discretion with patient information.

Department-Specific Responsibilities:

• Assists with patient screening, study visits, patient sample specimen collection, and processing in strict adherence to established procedures.
• Performs other related administrative tasks.

Qualifications

Education:

• High School Diploma/G.E.D., required.
• Bachelor's degree in Science, Sociology, or related degree, preferred.

Licenses/Certifications:

• ACRP/SoCRA (or equivalent) certification is preferred.

Experience:

• Clinical Research experience is highly preferred.
• Understanding of general research objectives.

Physical Demands:??

Standing, Walking, Sitting, Lifting 50 lbs. Carrying 50 lbs. Pushing?? 50 lbs.??Pulling 50 lbs.??Reaching, Handling, Grasping, Feeling, Talking,?? Hearing, Repetitive Motions, Eye/Hand/Foot Coordination

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.

Req ID : 598

Working Title : Clinical Research Associate I - Karsh Division of Gastroenterology and Hepatology

Department : Research - General Medicine

Business Entity : Cedars-Sinai Medical Center

Job Category : Academic / Research

Job Specialty : Research Studies/ Clin Trial

Overtime Status : NONEXEMPT

Primary Shift : Day

Shift Duration : 8 hour

Base Pay : $19.50 - $29.87

About Cedars-Sinai Medical Center

Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competi ... tive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.

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