Job Description

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

The Clinical Research Coordinator I works independently in a hybrid capacity to manage clinical study coordination, including the screening of patients and facilitating the informed consent process. This role is responsible for accurate data collection, regulatory compliance, and reporting study findings at staff meetings, while ensuring adherence to FDA and local Institutional Review Board guidelines. The position requires strong organizational skills and effective communication to support ongoing research activities and patient interactions.

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, study coordinator, patient screening, data collection, FDA compliance, informed consent, regulatory guidelines, research studies, clinical trials, HIPAA regulations

Job Tags

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

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