Clinical Research Regulatory Specialist

University of California - Los Angeles Health; Los Angeles (CA); Vor Ort; USD 46.000 - 91.000; Vollzeit

Zusammenfassung

University of California - Los Angeles Health is seeking a Regulatory Coordinator to support regulatory and compliance activities across a portfolio of investigational drug and device studies. The role requires strong communication, organization, problem-solving, and collaboration skills to manage multiple priorities and work with investigators, study teams, and stakeholders.

The ideal candidate has a bachelor's degree and at least 1 year of clinical research experience, with proficiency in

Qualifikationen

• Bachelor's Degree or equivalent combination of education and experience.
• Minimum of 1+ years of experience as a clinical researcher.
• 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.
• Organization 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.
• A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.
• Working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
• 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 ability to communicate medical, policy and administrative information in English.

Aufgaben

• Support regulatory and compliance activities across investigational drug and device studies.
• Assist with maintaining regulatory files and documentation.

Kenntnisse

Interpersonal skills

Communication

Organizational skills

Problem-solving

Team collaboration

Attention to detail

Regulatory compliance

Documentation management

Ausbildung

Bachelor's Degree

Tools

Adobe Acrobat

Microsoft Office

Excel

Jobbeschreibung

University of California - Los Angeles Health is seeking a Regulatory Coordinator to support regulatory and compliance activities across a portfolio of investigational drug and device studies. The role requires strong communication, organization, problem-solving, and collaboration skills to manage multiple priorities and work with investigators, study teams, and stakeholders.

The ideal candidate has a bachelor's degree and at least 1 year of clinical research experience, with proficiency in