Description
The Clinical Research Supervisor provides immediate supervision to routine research study coordination. They will service unit operations to ensure compliance with departmental and organizational policies, procedures, and defined internal controls. They will supervise operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. They will oversee planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). The Supervisor serves as a liaison with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support. The responsibilities outlined in the job description provide a general overview of duties and tasks performed in the role. Performance of duties and tasks will vary based on the department operations, the type of study and scope of service
Salary Range: $86,400.00 - $184,800.00 Annually
Qualifications
Required:
- Bachelor's Degree in related area
and/or equivalent combination of education and experience. - 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. - Ability to effectively communicate to
and interact with patients in a compassionate and kind manner. Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions. 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. 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... - 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
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
manage complex and sometimes conflicting departmental priorities and external timelines.
Preferred:
- Clinical
Research Certification (CCRP, ACRP, etc.)
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