Hershey, Pennsylvania
Everett, Washington
Nashville, Tennessee
Posted: 27-Dec-24
Location: Los Angeles, California
Categories:
Internal Number: 145443187
The Clinical Research Supervisor oversees moderate/complex research study coordination. They will supervise unit operations to ensure compliance with departmental and organizational policies, procedures, and defined internal controls. They will also supervise operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. They oversee the 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). They will serve as 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 the role. Performance of duties and tasks will vary based on the department operations, the type of study and scope of service.
Salary Range: $92,600.00 - 202,200.00 Annually
Required:
- Bachelor’s degree required, Master’s degree preferred
- Minimum of 5+ years of experience in clinical research coordination
- Minimum 2+ years of direct clinical research supervision
- Expert level experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets.
- Expert level experience with FDA processes and procedures.
- Demonstrated ability to serve as a subject matter expert, providing guidance and advice to lower level clinical research coordinators.
- Expert level working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
- Demonstrated ability to interpret IRB, FDA, federal and UCLA requirements and utilize that information to guide investigators and other team members.
- 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.
- 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
- 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.
- 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.
- Ability to handle confidential information with judgement and discretion.
- Availability to work in more than one environment, traveling to various clinic sites, meetings, conferences, etc
- Demonstrated analytical skills to address problems of high complexity.
- Ability to think creatively to develop solutions affecting the full team.
- Ability to lead the development and implementation of quality improvement activities, SOPs, processes, 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
- Experience with employee relations and HR issues.
- Ability to independently and autonomously lead a large and complex unit
- Clinical Research Certification (CCRP, ACRP, etc.)
