Clinical Research Associate I - Department ofPediatrics - Pediatric Nephrology (Part-Time)

Job Description

Come join our team!

TheClinical Research Associate I works directly with a ClinicalResearch Coordinator, Research Program Administrator, or ResearchNurse to coordinate and / or implement the study.

Evaluates andabstracts research data and ensures compliance with protocol andresearch objectives. Responsible for completing case report forms,entering clinical research data, and assist with regulatorysubmissions to the IRB.

Provides limited patient contact as neededfor study and assist with study budget and patient researchbilling. Ensures compliance with all federal, local, FDA, IRB, andHIPAA guidelines and regulations pertaining to the study andpatient care.

Primary Duties andResponsibilities

• Works with a ClinicalResearch Coordinator, Research Program Administrator or ResearchNurse to coordinate / implement study.
• Evaluatesand abstracts clinical research data from sourcedocuments.
• Ensures compliance with protocol andoverall clinical research objectives.
• CompletesCase Report Forms (CRFs).
• Enters clinicalresearch data into Electronic Data Systems (EDCs) that are providedby the sponsors.
• Provides supervised patientcontact or patient contact for long term follow-up patientsonly.
• Assists with regulatory submissions tothe Institutional Review Board (IRB) including submission ofAdverse Events, Serious Adverse Events, and Safety Letters inaccordance with local and federalguidelines.
• Assists with clinical trialbudgets.
• Assists with patient researchbilling.
• Schedules patients for research visitsand research procedures.
• Responsible for samplepreparation and shipping and maintenance of study supplies andkits.
• Ensures compliance with all federal andlocal agencies including the Food and Drug Administration (FDA) andlocal Institutional Review Board.
• Maintainsresearch practices using Good Clinical Practice (GCP)guidelines.
• Maintains strict patientconfidentiality according to HIPAA regulations and applicablelaw.
• Participates in required training andeducation programs.

Qualifications

EducationalRequirements :

• High School Diploma / GEDrequired
• Bachelor's Degree in Science,Sociology or related degree preferred

Licenses / Certifications :

Nolicense or certification required

Experience :

One (1) year ofclinical research related experiencepreferred

AboutUs

Cedars-Sinai is a leader inproviding high-quality healthcare encompassing primary care,specialized medicine and research.

Since 1902, Cedars-Sinai hasevolved to meet the needs of one of the most diverse regions in thenation, setting standards in quality and innovative patient care,research, teaching and community service.

Today, Cedars- Sinai isknown for its national leadership in transforming healthcare forthe benefit of patients. Cedars-Sinai impacts the future ofhealthcare by developing new approaches to treatment and educatingtomorrow's health professionals.

Additionally, Cedars-Sinaidemonstrates a commitment to the community through programs thatimprove the health of its most vulnerableresidents.

About theTeam

Cedars-Sinai is one of thelargest nonprofit academic medical centers in the U.S., with 886licensed beds, 2,100 physicians, 2,800 nurses and thousands ofother healthcare professionals and staff.

Choose this if you wantto work in a fast-paced environment that offers the highest levelof care to people in the Los Angeles that need our care the most.

Req ID : 4148

Working Title : Clinical ResearchAssociate I - Department of Pediatrics - Pediatric Nephrology(Part-Time)

Department : Research -Pediatrics

Business Entity : Cedars-Sinai Medical Center

JobCategory : Academic / Research

JobSpecialty : Research Studies / ClinTrial

Overtime Status : NONEXEMPT

Primary Shift : Day

Shift Duration : 8hour

Base Pay : $19.50 -$29.87