CLIN RSCH CRD

UCSF•San Francisco, CA

About The Position

This is a limited appointment that will end when the project concludes or when the incumbent reaches 1,000 hours worked, whichever occurs first. The Clinical Research Coordinator will perform independently or with general direction at the fully operational, journey level of the series to execute, manage, and coordinate research protocols. This role operates under the guidance of the Clinical Research Supervisor and/or Principal Investigator (PI) within the Department of Pediatrics and may support multiple concurrent clinical research studies in accordance with research protocols, UCSF policies, and regulatory agency requirements. Responsibilities include, but are not limited to, managing and coordinating activities for one or more clinical research studies, depending on size and complexity; serving as a liaison between departments and services; and overseeing data and specimen management. The incumbent will create, maintain, and analyze databases and comprehensive datasets; manage and report study results; and support scheduling and coordination of study team activities. Additional duties include managing investigator protocols within the Committee on Human Research (CHR) system, including submissions, renewals, and modifications; supporting the initiation of new studies; and assisting in the preparation and review of study protocols to ensure Institutional Review Board (IRB) approval and compliance with university and regulatory standards. The role also ensures adherence to all applicable regulatory requirements, maintains study documentation, monitors data integrity, and implements quality control procedures. The Clinical Research Coordinator will interface with internal departments to obtain required approvals, report study progress to investigators, and participate in internal and external audits. Other duties may be assigned as needed.

Requirements

Perform independently or with general direction at the fully operational, journey level of the series to execute, manage, and coordinate research protocols.
Operate under the guidance of the Clinical Research Supervisor and/or Principal Investigator (PI) within the Department of Pediatrics.
Support multiple concurrent clinical research studies in accordance with research protocols, UCSF policies, and regulatory agency requirements.

Responsibilities

Manage and coordinate activities for one or more clinical research studies.
Serve as a liaison between departments and services.
Oversee data and specimen management.
Create, maintain, and analyze databases and comprehensive datasets.
Manage and report study results.
Support scheduling and coordination of study team activities.
Manage investigator protocols within the Committee on Human Research (CHR) system, including submissions, renewals, and modifications.
Support the initiation of new studies.
Assist in the preparation and review of study protocols to ensure Institutional Review Board (IRB) approval and compliance with university and regulatory standards.
Ensure adherence to all applicable regulatory requirements.
Maintain study documentation.
Monitor data integrity.
Implement quality control procedures.
Interface with internal departments to obtain required approvals.
Report study progress to investigators.
Participate in internal and external audits.