Description
The Division of Pediatric Infectious Diseases within the David Geffen School of Medicine at UCLA Health is seeking a Quality Assurance Manager who will work closely with Protocol Team Leadership to implement clinical trials protocols and coordinate laboratory-related committees and working groups.
The Quality Assurance Manager will also review protocol testing, laboratory quality assurance information, and support capabilities required to conduct global clinical trials.
Please ensure you read the below overview and requirements for this employment opportunity completely.
Salary Range : $83,800 - $179,400 Annually
Qualifications
Required :
- Bachelor’s degree
- Minimum of 5+ years of experience in a clinical regulatory role
- Minimum 2+ years of direct clinical research supervisory experience
- Expert knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
- 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.
- Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations.
- Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.
- Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment.
- Organizational skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met.
- Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.
- Advanced 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.
- Demonstrated analytical skills to address problems of high complexity.
- Experience with FDA processes and procedures.
- Demonstrated ability to interpret IRB, FDA, federal and UCLA requirements and utilize that information to guide investigators and other team members.
- Team leadership experience (i.e. projects, committees, etc.).
- 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.
- Ability to develop and give presentations to leadership, positively representing the department.
- Experience with employee relations and HR issues.
Preferred :
Master’s degree
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