Clinical Research Supervisor

University of California, Irvine•Orange, CA

7d•Onsite

About The Position

The Clinical Research Supervisor 1 will manage day-to-day research operations and provide comprehensive oversight for clinical research activities within the Department of Radiology by providing comprehensive coordination and data management of research studies and sponsored clinical trials according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures. Incumbent is responsible for reviewing study protocols to ensure effective execution and adherence to all regulatory and institutional requirements. Working under the guidance of research faculty, the supervisor blends hands‑on coordination with team management, supporting both the strategic and practical needs of the research portfolio. Serving as a central liaison, the Clinical Research Supervisor 1 facilitates communication and collaboration among research staff, principal investigators, sponsors, regulatory and compliance offices, and other institutional partners. The position supports and oversees clinical research faculty and staff working across a variety of investigators, programs, and therapeutic areas. Incumbent will also help in data curation, identifying and selecting problems for investigation and planning experiments, which may include but not limited to literature searches, data review, database creation and maintenance, manuscript preparation, and submissions. Incumbent will also coordinate the radiology safety read and special read (i.e. RECIST, RANO, CHESON, etc) services for IRB- approved studies. Lastly, incumbent will perform root cause analysis to establish and/or maintain smooth research workflow/operations.

Requirements

Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical research.
Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research.
Ability to think critically in compiling and reviewing data from various sources.
Ability to perform scientific research including properly evaluating information and preparing concise, well-organized reports and correspondence.
Database creation and maintenance using Excel and/or other relational databases.
Research experience especially with IRB, IACUC, HIPAA and other regulatory documents, study coordination and familiar with GCP and ethical conduct of research.
Excellent verbal and written communication skills and ability to interact with the public, faculty, and staff.
Ability to establish and maintain files and records.
High level of integrity and honesty in maintaining confidentiality.
Ability to quickly evaluate complex issues and identify multiple options for resolutions.
Ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds.
Bachelor's degree in related area and / or equivalent experience / training.
7+ years of related work experience.
Must be able to provide proof of work authorization.

Nice To Haves

Experience in clinical coordination.
Familiar with UC system experience and knowledge of UC policies and procedures.
Familiar with internal systems such as EPIC, Redcap, OnCore, and Kuali Financial System.
Advanced degree preferred.
Certified Clinical Research Professional (CCRP).

Responsibilities

Manage day-to-day research operations and provide comprehensive oversight for clinical research activities within the Department of Radiology.
Provide comprehensive coordination and data management of research studies and sponsored clinical trials according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures.
Review study protocols to ensure effective execution and adherence to all regulatory and institutional requirements.
Blend hands‑on coordination with team management, supporting both the strategic and practical needs of the research portfolio.
Facilitate communication and collaboration among research staff, principal investigators, sponsors, regulatory and compliance offices, and other institutional partners.
Support and oversee clinical research faculty and staff working across a variety of investigators, programs, and therapeutic areas.
Assist in data curation, identifying and selecting problems for investigation and planning experiments.
Perform literature searches, data review, database creation and maintenance, manuscript preparation, and submissions.
Coordinate the radiology safety read and special read (i.e. RECIST, RANO, CHESON, etc) services for IRB- approved studies.
Perform root cause analysis to establish and/or maintain smooth research workflow/operations.