Clinical Research Coordinator II (Imaging) Los Angeles, CA

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Job Description
This role follows a hybrid work schedule with a minimum requirement of four days onsite per week at our Los Angeles work location. Applicants must be able to meet this onsite requirement and if hired must reside within a commutable distance of the work location.

This Clinical Research Coordinator II position offers an opportunity to play a meaningful role in the successful conduct of clinical trials. While the position is not patient-facing in a direct clinical care capacity it is patient-adjacent and highly involved in the regulatory and operational aspects of clinical research.

In this role you will support key activities across the clinical trial lifecycle including:

Screening participants for protocol eligibility
Supporting the informed consent process
Maintaining accurate source documentation related to research visits
Coordinating protocol-defined enrollment activities and timelines
Supporting Adverse Event (AE) and Serious Adverse Event (SAE) documentation and reporting related to participant safety
Helping ensure research activities remain compliant with FDA OHRP IRB sponsor and protocol requirements

This is an excellent opportunity for a clinical research professional who enjoys working in a highly regulated environment managing time-sensitive responsibilities and contributing to both participant safety and research integrity.

The CRC II serves as an important partner to investigators research teams sponsors and regulatory stakeholders helping ensure clinical trials are conducted accurately responsibly and in accordance with applicable requirements.

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.

Required Experience:

IC