Clinical Research Coordinator II - Research Institute

Clinical Research Coordinator II - Research Institute

The Clinical Research Coordinator II works independently providing study coordination including screening of 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 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).

• Schedules patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
• Maintains accurate source documents related to all research procedures.
• Schedules and participates in monitoring and auditing activities.
• 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.
• 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 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.

• Education:
  
  High School Diploma/GED required;
  Bachelor’s degree in Science, Sociology, or related field preferred.
• Licenses/Certifications:
  
  ACRP/SoCRA certification preferred.
• Experience:
  
  2 years of clinical research experience required.

Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service.

Req

Working Title:

Clinical Research Coordinator II - Research Institute

Department:
Research Institute

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: $58,864.00 - $