Cedars-Sinai Clinical Research Associate I in Los Angeles, California
Clinical Research Associate I Requisition # 29619
Summary of Essential Job Duties:
The Cedars-Sinai F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute (IBIRI) is searching for a Clinical Research Associate I (CRAI). IBIRI is a multidisciplinary basic, translational and clinical research program devoted to Inflammation Bowel Diseases. Under the direction of Dr. Dermot McGovern, the institute is seeking for a talented and highly motivated candidate to join the group as a CRAI.
The CRAI position, is also known as a Tissue procurement specialist in Translational Medicine IBIRI is expected to fulfill the following departmental specific job responsibilities:
Understanding and implementation of research protocol details within current IRB/HIPAA regulatory rules to obtain specimens for research in various hospital environments - specifically communicating accurately and effectively with research subjects, clinicians, and researchers with diverse backgrounds during surgeries and endoscopies; entering and maintaining accurate patient/study data in databases; performing laboratory procedures to prepare samples for further experiments, storage, or shipping. Computer skills, including Word and Excel, and ability to use standard office equipment is required. This position may require on-site training by other experienced clinical research associates.
The CRAI may work directly with Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate and/or implement the study. This role evaluates and abstracts research date and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and may assist with study budget and patient research billing. This role will comply with all federal, local, FDA, IRB and HIPAA guidelines and regulations pertaining to the study and patient care.
Essential job duties and responsibilities may include but not limited to:
• Work with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
• Evaluates and abstracts clinical research data from source documents.
• Ensures compliance with protocol and overall clinical research objectives.
• Completes Case Report Forms (CRFs).
• 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.
• Assists with 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.
Participate in required training and education programs.
Understand and implement the current IRB/HIPPA regulatory rules and research protocol details
-Communicate accurately and effectively with research subjects, clinicians, and researchers, from diverse backgrounds.
Work in various hospital environments during surgeries and endoscopies to obtain specimens for research
Enter and maintain accurate patient/study data in databases
Perform laboratory procedures to prepare samples for further experiments, storage, or shipping, including DNA extraction and quantification from saliva and cell pellets
Must possess computer skills, including Word and Excel, and ability to use standard office equipment is required.
Education Certifications/Licensure Experience Physical Abilities Educational Requirements:
BA/BS degree, or equivalent combination of education and experience
Valid CA Driver's License and liability (minimum) car insurance
Understanding of general research objectives and prior research experience is preferred
Physical Demands: (e.g., lifting, standing, walking)
Able to perform moderate lifting. May require occasional driving to offsite location. Able to sit, stand, and walk for prolonged periods of time. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions
- Working Title: Clinical Research Associate I
- Business Entity: CSMC - Cedars-Sinai Medical Center
- Cost Center # - Cost Center Name: 0801102 - Home Dept - Gastroenterology
- City: Los Angeles
- Job Category: Research/Research Admin
- Job Specialty: Clinical Research
- Position Type: Regular-F/T
- Shift Length: 8hr
- Hours: 8am - 4:30pm
- Days: Monday - Friday
- Shift Type: Day
- Weekends: As Needed
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through March each year) as a condition of employment, and annually thereafter as a condition of continued employment.