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Cedars-Sinai Clinical Research Assoc I Per Diem in West Hollywood, California

Job Summary:

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 abstract research data and ensure compliance

with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and

assisting with regulatory submissions to the IRB. Provides limited patient contact for study and assists 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.

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 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

Radiation Oncology Works directly with a radiation oncologist, medical physicist, and/or biostatistician to perform

clinical research studies.

Radiation Oncology Designs forms for data collection/abstraction. Performs data collection/abstraction.

Radiation Oncology Processes clinical data using a range of computer applications and database systems.

Radiation Oncology Performs data searches and other related administrative tasks.

Radiation Oncology Assists with research protocol writing and development.

Performs phlebotomy services according to CSMS policies and procedures. Verifies specimen

identification, assesses the appropriateness of test orders and quality of specimen by recognizing

factors that affect procedures and results; takes appropriate action when corrections are

indicated. Identifies patients and patient samples by strict adherence to established

procedures; labels samples accurately and completely. Reports test results to

appropriate individuals and exercises professional discretion with patient information.

Educational Requirements:

High School Diploma/GED-Minimum

Bachelor's Degree-Preferred

Licenses:

Phlebotomy Certification CA

Experience:

1-year of Clinical Research Related Experience

Physical Demands:

Standing, Walking, Sitting, Lifting 50 lbs. Carrying 50 lbs. Pushing 50 lbs. Pulling 50 lbs. Climbing, Balancing, Stooping

Kneeling, Crouching, Crawling, Reaching, Handling, Grasping, Feeling, Talking, Hearing, Repetitive Motions

Eye/Hand/Foot Coordination

Working Title: Clinical Research Assoc I Per Diem

Department: Cancer Resrch Ctr Health Eqty

Business Entity: Academic / Research

Job Category: ,Academic/Research,Academic/Research

Job Specialty: Research Studies/Clinical Trials

Position Type: Full-time

Shift Length: 8 hour shift

Shift Type: Day

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.

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