Clinical Research Associate I - Karsh Division of Gastroenterology and Hepatology
Cedars-Sinai · Los Angeles, California
What the posting says
Each fact was read from this posting and checked:Statedin the posting, quotedConflictsposted two ways, both shownNot mentionedwe looked; it is not there
- Employment typeStated
- Full time
- Work arrangementStated
- On-site
- EducationStated
- ['high school', 'bachelor degree', 'professional certificate']
Not mentioned in this posting
We read the whole posting. These are not in it. Not a no: ask the recruiter, in your own words.
- PayNot mentioned
- The posting does not say
- ShiftNot mentioned
- The posting does not say
- ExperienceNot mentioned
- The posting does not say
- Visa sponsorshipNot mentioned
- The posting does not say
Requirements, each with its sentence from the posting
These are the employer’s words. The index does not judge whether you meet them.
- High School Diploma or GEDrequired
High School Diploma/GED is required
from the posting - Bachelor's degree in Science or related fieldpreferred
Bachelor's degree in Science, Sociology, or related degree is preferred
from the posting - Clinical research experiencepreferred
Clinical research experience is highly preferred
from the posting - ACRP or SoCRA certificationpreferred
ACRP/SoCRA certification is preferred
from the posting - Data entry and managementimplied
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors
from the posting - Case report form completionimplied
completing case report forms (CRFs), entering clinical research data
from the posting - IRB complianceimplied
Assists with regulatory submissions to the Institutional Review Board (IRB)
from the posting - HIPAA complianceimplied
Maintains strict patient confidentiality according to HIPAA regulations
from the posting - Good Clinical Practice (GCP) guidelinesimplied
Maintains research practices using Good Clinical Practice (GCP) guidelines
from the posting
Read the full posting as the employer wrote it
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 Karsh Division of Gastroenterology and Hepatology offers trusted care from doctors and researchers who have pioneered many of the diagnostic techniques and surgical treatments widely used to treat digestive and liver diseases.
Dr. Walid Ayoub, MD is looking for a Clinical Research Coordinator I to join his research team. Dr. Ayoub is the Director of the Autoimmune and Cholestatic Liver Disease Program at Cedars-Sinai Medical Center.
As a Clinical Research Associate I, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. This position will be responsible for completing case report forms (CRFs), entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). The CRA I member may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Job Duties and Responsibilities:
- Ensures compliance with protocol and overall clinical research objectives.
- 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.
- 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 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.
Qualifications
Education:
- High School Diploma/GED is required.
- Bachelor's degree in Science, Sociology, or related degree is preferred.
Licenses/Certifications:
- ACRP/SoCRA certification is preferred.
Experience:
- Clinical research experience is highly preferred.
- Understanding of general research objectives.
About the organization
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.The posting text is reproduced as the employer wrote it; the index adds nothing to it.