Job Description

Clinical Research Coordinator I (Hybrid) at CEDARS-SINAI summary:

The Clinical Research Coordinator I (Hybrid) is responsible for the independent coordination of clinical studies, ensuring compliance with protocols and regulations while screening potential patients for eligibility. This role includes accurate data collection, documentation, and reporting, as well as active participation in the informed consent process and maintaining proper compliance with FDA and IRB guidelines. The position requires effective communication and regular presentation of study information to research staff while upholding patient confidentiality and adhering to Good Clinical Practice (GCP).

Job Description

This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.

The Clinical Research Coordinator I works 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.

Qualifications

This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.

Requirements:

• High School Diploma/GED.
• 1 year Clinical research experience. 
• Please note that this role requires a onsite presence of at least 3 days a week.

Preferred:

• Bachelor's Degree Science, Sociology or related degree 
• Certification In Clinical Research SOCRA or ACRP certification

Req ID : 5313
Working Title : Clinical Research Coordinator I (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 : $23.39 - $39.76

Keywords:

Clinical Research, Clinical Trials, Research Coordinator, Patient Screening, FDA Compliance, IRB Oversight, Data Collection, Healthcare Research, Good Clinical Practice, Clinical Research Experience

Job Tags

Full time, Local area, Shift work, 3 days per week,

Similar Jobs