Description
The Department of Medicine is seeking a Clinical Research Unit Supervisor to lead and oversee the coordination of clinical research studies. In this role, you will provide direct supervision to research staff and ensure the smooth operation of study activities from design and setup through conduct and closeout. You will manage unit operations to guarantee compliance with departmental policies, organizational standards, and regulatory requirements, including FDA Code of Federal Regulations (CFR), ICH Good Clinical Practice (GCP), and institutional procedures. As a key liaison, you will collaborate with Principal Investigators, sponsors, central research infrastructure teams, ancillary departments, and other stakeholders to support all aspects of study administration-including compliant study conduct, financial oversight, and personnel management. Your leadership will ensure studies are executed efficiently, ethically, and in full alignment with protocol and regulatory guidelines. This role offers the opportunity to make a meaningful impact on research operations while mentoring a team and supporting high-quality clinical research within the Department of Medicine. Annual range: $86,400-$184,800
Qualifications
Required:
- Bachelor's Degree in related area. Advanced degree
preferred - Minimum of 5+ years of experience in a clinical research
setting - Interpersonal skills to effectively communicate information
in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team. - Analytical skills to assess clinical research protocols and
regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions. - Demonstrated proficiency with Adobe and Microsoft suite
software, especially Excel and Word, to perform daily tasks efficiently and accurately. Ability to learn additional systems, including DocuSign, Florence eBinders, and others as needed. - Knowledge of and experience working with a variety of local
and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. - Ability to handle confidential information with judgement
and discretion. - Availability to work in more than one environment,
travelling to various clinic sites, meetings, conferences, etc, including out of state network and investigator meetings. - Demonstrated ability to interpret IRB, FDA, federal and
UCLA requirements and utilize that information to guide investigators and other team members. - Expert level working knowledge of clinical research
concepts, policies and procedures, and human safety protection regulations and laws. - Demonstrated experience and knowledge of clinical trials
budgeting processes to manage the preparation of clinical trials budgets. - Demonstrated experience with FDA processes and procedures.
- Ability to lead the development and implementation of
quality improvement activities, SOPs, processes, etc. - Team leadership experience (i.e. projects, committees,
etc.). - Ability to develop and give presentations to leadership,
positively representing the department. - Ability to predict potential problems and proactively
implement solutions. - Ability to clearly communicate complex departmental and
institution-wide policies and ensure understanding. - Ability to manage complex and sometimes conflicting
departmental priorities and external timelines.
Preferred:
- Clinical Research Certification (CCRP, ACRP, etc.)
- Experience with laboratory standards and functions
including Good Clinical Laboratory Practice (GCLP) - Demonstrated ability to prepare for, facilitate, and
respond to site monitoring visits and audits in compliance with FDA, GCP, ICH guidelines, and sponsor requirements. - Familiarity with grant and other report writing
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