Clinical Research Coordinator

iHire; Los Angeles (CA); Hybrid; Full time

Job summary

A leading healthcare institution in Los Angeles is recruiting a Clinical Research Coordinator II to oversee various study coordination tasks. The successful candidate will ensure compliance with regulatory guidelines, manage patient interactions, and maintain study documentation in line with federal standards. They will work in a hybrid capacity and contribute to enhancing patient enrollment and research efficiency.

Qualifications

• Experience in clinical research (2 years required).
• Knowledge of Good Clinical Practice (GCP).
• Understanding of regulatory requirements.

Responsibilities

• Coordinates study activities and schedules patients for research visits.
• Maintains accurate documentation and ensures compliance with regulations.
• Compiles and presents study reports at staff meetings.

Skills

Attention to detail

Communication

Education

Bachelor's Degree in Science, Sociology or related degree

High School Diploma/GED

Job description

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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 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).

Primary Duties And 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

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 required. Bachelor's Degree Science, Sociology or related degree preferred.
• 2 years Clinical research related experience required.
  
  

#Jobs-Indeed

Req ID : 8277

Working Title : Clinical Research Coordinator I Data Management (Hybrid)

Department : Cancer - SOCCI Clinical Research

Business Entity : Cedars-Sinai Medical Center

Job Category : Academic / Research

Job Specialty : Research Studies/ Clin Trial

Overtime Status : EXEMPT

Primary Shift : Day

Shift Duration : 8 hour

Base Pay : $28.30 - $48.11

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science, Research, and Engineering

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