The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. 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 as needed for study and assist with study budget and patient research billing. 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 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) including submission of 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. * Participates in required training and education programs.
Department-Specific Responsibilities Additional primary duties and responsibilities that are only performed in the specific department(s) below:
Radiation Oncology * Works directly with a radiation oncologist, medical physicist, and/or biostatistician to perform clinical research studies. * Designs forms for data collection/abstraction. Performs data collection/abstraction. * Processes clinical data using a range of computer applications and database systems. * Performs data searches and other related administrative tasks. * Assists with research protocol writing and development.
Phlebotomy * Performs phlebotomy services according to CSMS policies and procedures. Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; take appropriate action when corrections are indicated. Identifies patients and patient samples by strict adherence to established procedures; labels samples samples accurately and completely. Reports test results to appropriate individuals and exercises professional discretion with patient information.
Educational Requirements: Bachelor's Degree Degree in Science, Sociology or related degree (preferred)
Licenses: Phlebotomy Certification CA - Required for only some positions
* 1 year Clinical Research Related Experience (preferred) * Regulatory - Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations
Physical Demands: Must possess the physical ability and perceptive acuity to satisfactorily perform all direct and indirect patient care functions
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 t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive 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.