Clinical Research Coordinator II, Hybrid

Our take on this role

About this role

Coordinate research studies, screen patients for eligibility, explain non-medical trial details, and maintain study records. The hybrid schedule expects four on-site days per week in Los Angeles.

What could you bring from clinical work?

• Nurses: Your experience documenting clinical observations, medication use, and adverse events could help with maintaining accurate research source documents.
• OTs: Collecting functional outcome data and maintaining clinical records could help you collect study data and respond to sponsor queries.
• PTs: Tracking outcomes and participating in clinical quality improvement could help when the role involves identifying improvement opportunities and developing action plans.
• Social workers and SLPs: If you've explained complex care or service information to patients, that experience may help you explain trial details and participate in informed consent.

Full job description from Cedars-Sinai

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

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.

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