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Cedars-Sinai Clinical Research Coordinator I /Certified Phlebotomy Technician -CCTO in Los Angeles, California

Job Summary:

The Clinical Research Coordinator I will work independently providing study coordination, screening of potential patients for protocol eligibility, communicating non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities:

•Independent study coordination including screening of potential patients for protocol eligibility, communicating non-medical trial concepts and details to the patients, and participating in the informed consent process.

•Schedules patients for research visits and procedures.

•In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.

•Maintains accurate source documents related to all research procedures.

•Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.

•Schedules and participates in monitoring and auditing activities.

•Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.

•Notifies direct supervisor about concerns regarding data quality and study conduct.

•Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.

•May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.

•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.

Skill/Knowledge/Ability Description

Regulatory - Ability to use discretion and maintain privacy, confidentiality or anonymity Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Regulatory - Ability to interpret and apply knowledge of State, Federal and Agency standards to align with regulations Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

Communication - Ability to convey and/or receive written/verbal information to/from various audiences in different formats

Educational Requirements:

High School Diploma/GED - Minimum

Bachelor's Degree Science, Sociology or related degree

Licenses:

No license or certification required

Certification In Clinical Research SOCRA or ACRP certification

Experience:

1 year Clinical research related experience

1 year Involvement in Coordination of Clinical Research Trials

Working Title: Clinical Research Coordinator I /Certified Phlebotomy Technician -CCTO

Department: SOCCI Clinical Research Office

Business Entity: Academic / Research

Job Category: 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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