Clinical Research Associate II, Data Coordinator (Hybrid)

Details

Posted: 12-May-24

Location: California

Salary: Open

Categories:

Academic/Faculty

Internal Number: 2323

Job Description

The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB.

Provides limited patient contact with research participants as needed for study and assist with study budget and patient research participant research billing. In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Primary Duties and Responsibilities

• Works with a Clinical Research Coordinator,Research Program Administrator, Research Nurse, or Principal Investigator to coordinate/implement study.
• Evaluates and abstracts clinical research data from source documents.
• Completes Case Report Forms (CRFs).
• Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Provides supervised contact with research participants or contact for long term follow-up research participants 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.
• Schedules research participants 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. May be involved in training and education of other Clinical Research Associates.
• Serves as the point of contact for external sponsors for select trials.
• Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives.
• Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
• May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications

Qualifications
Requirements:

• High School Diploma/GED required. Bachelor's Degree preferred.
• 1 year of Clinical Research Related Experience required.

#Jobs-Indeed

Req ID : 2323
Working Title : Clinical Research Associate II, Data Coordinator (Hybrid)
Department : Cancer - SOCCI Clinical Research
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 : $23.00 - $36.14

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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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