Clinical Research Coordinator II - Surgery Chair

Cedars-Sinai; Los Angeles (CA); Presencial; USD 75.000 - 110.000; Jornada completa

Descripción de la vacante

Cedars-Sinai in Los Angeles seeks a detail-oriented Clinical Research Coordinator II to independently coordinate studies, screen potential patients for protocol eligibility, obtain informed consent, and manage source documents, data collection, and reporting.

You will work with physicians and IRB, ensure compliance with FDA and HIPAA, monitor safety, prepare CRFs, and support enrollment strategies while maintaining high quality and timely sponsor communications.

Formación

• High School Diploma/GED - Required.
• Bachelor's Degree in Science, Sociology or related degree - Preferred.
• 2 years clinical research related experience - Required.
• Preferred SOCRA or ACRP certification.

Responsabilidades

• Coordinate screening of potential patients for protocol eligibility.
• Document thoroughly on Case Report Forms (CRFs) adverse events and protocol changes.
• Maintain accurate source documents for all research procedures.
• Manage data collection, entry and sponsor query responses in a timely way.
• Schedule visits, monitoring, and auditing activities for studies.
• Collaborate with physicians and IRB to submit safety reports and deviations.
• Support enrollment strategies and identify new research opportunities.

Conocimientos

GCP knowledge

HIPAA compliance

IRB coordination

Educación

High school diploma / GED

Bachelor's degree in Science/Sociology or related

Descripción del empleo

Job Description

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).

• 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 - Required
• Bachelor's Degree Science, Sociology or related degree - Preferred

Experience

• 2 years Clinical research related experience - Required

Licenses and Certifications

• - Preferred SOCRA or ACRP certification

Education

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

Experience

• 2 years Clinical research related experience - Required

Licenses and Certifications

• - Preferred SOCRA or ACRP certification