Job Description

Clinical Research Coordinator II, Per Diem - ASPIRE at CEDARS-SINAI summary:

The Clinical Research Coordinator II manages study operations including patient screening, scheduling, data collection, and regulatory compliance, ensuring all research activities adhere to FDA, IRB, and Good Clinical Practice guidelines. They independently coordinate study documentation, report accrual and research metrics, and participate in audits and quality improvement initiatives. With clinical research experience and strong organizational skills, this role supports efficient, compliant, and effective research practices in a hospital setting.

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).

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

Requirements:

• High School Diploma/GED required. Bachelor's Degree Science, Sociology or related degree preferred.
• 2 years Clinical research related experience required.

Preferred Skills:

• Proven ability to develop and maintain relationships with key community organizations and stakeholders to support and promote community-based research initiatives.
• Experience representing programs at community events, conferences, health fairs, and other outreach activities to build partnerships, enhance visibility, and support participant recruitment efforts.
• Strong organizational skills to coordinate specific aspects of program planning and research implementation, ensuring adherence to timelines and achievement of defined outcomes.
• Ability to perform general office duties including photocopying, preparing informational packets, answering phones, and maintaining organized filing systems.
• Competence in assisting with data collection, conducting basic analysis, and contributing to the preparation of research reports and summaries.
• Strong written communication skills to draft professional emails, documents, and correspondence as needed.
• Physical ability to lift and carry items weighing up to 20 pounds.
• Flexibility to work occasional evenings and weekends based on program or research needs.

Req ID : 8213
Working Title : Clinical Research Coordinator II, Per Diem - ASPIRE
Department : Cancer - Research Center Health Equity
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, clinical trial coordinator, patient screening, informed consent, regulatory compliance, data collection, GCP, FDA, IRB, research documentation

Job Tags

Full time, Local area, Shift work, Afternoon shift,

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