Job Description

　　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. With a team focused on effective pain management and quick recovery, Cedars-Sinai has been ranked as the No. 1 hospital in Southern California for Orthopaedics by U.S. News & World Report. Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!

　　The Clinical Research Associate I (CRAI) will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants as needed for study and assists with study bu/long term follow-up research participants only.

　　Primary Duties & 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

　　Qualifications

　　Educational Requirements:

　　· High School Diploma/GED

　　Bachelors degree in science or related degree preferred

　　Experience:

　　1-year clinical research related experience preferred

　　Physical Demands:

　　Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

　　Understanding of​ general clinical research objectives. Clinical research experience, preferred

　　Req ID : 481

　　Working Title : CSMC 8270303 Dept of Orthopaedics Clinical Research Associate I FR 31684 Monetti R06 1.00

　　Department : Dept of Orthopaedics

　　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 : $19.50 - $29.87

　　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.