Clinical Research Coordinator II, Hybrid

Cedars-Sinai; Beverly Hills (CA); Hybrid; USD 65,000 - 85,000; Full time

Job summary

Cedars-Sinai in Los Angeles is hiring a Clinical Research Coordinator II for a hybrid role requiring four on-site days per week. The coordinator will screen patients for protocol eligibility, present trial concepts, and participate in informed consent processes.

Responsibilities include coordinating data collection, maintaining source documents, and reporting to sponsors. The role requires collaboration with physicians and IRB to ensure GCP and HIPAA compliance.

Qualifications

• Requires completion of High School Diploma or GED; Bachelor's degree preferred in Science, Sociology or related field.
• 2+ years Clinical research experience preferred.
• Familiarity with FDA/IRB regulations and GCP guidelines.

Responsibilities

• Coordinate independent study activities including screening patients for protocol eligibility.
• Schedule patients for research visits and procedures.
• Document changes in patient condition and protocol adherence on Case Report Forms (CRFs).
• Maintain accurate source documents for all research procedures.
• Collect, document, and report data; respond to sponsor queries promptly.

Skills

Study coordination

Patient screening

Informed consent

Data collection

Documentation

Regulatory compliance

IRB liaison

HIPAA compliance

GCP guidelines

Education

High School Diploma/GED

Bachelor's Degree in Science or related

Sociology or related degree

Job description

Job Description

This role follows a hybrid work schedule with an expected on-site presence of 4 days per week. Applicants must be able to commute to our Los Angeles work location and, if hired, must reside within a commutable distance.

The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting 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 information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Responsibilities:

• Independent study coordination including screening of potential patients for protocol eligibility, presenting 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.
• May coordinate training and education of other personnel.
• May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• May identify new research opportunities and present to investigators
• Participates in required training and education programs.

Qualifications

Education

• High School Diploma/GED - minimum
• Bachelor's Degree Science, Sociology or related degree - preferred

Experience

• 2 years Clinical research related experience - minimum

Licenses and Certifications

• preferred SOCRA or ACRP certification