The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the "Trojan Family," which is comprised of the faculty, students and staff that make the university what it is.
The position of Multi-site Coordinating Center Coordinator will be a full-time exempt position which has the following responsibilities:
USC CISO Multi-Site Coordinating Center leadership: Provides consistent leadership as well as operational and general oversight of the Multi-site Coordinating Center to ensure competent and standardized practices that are compliant with all institutional and regulatory requirements. The coordinating center coordinator supervises, monitors and supports the timely study start up, administration and progress of USC CISO led clinical research conducted at multiple institutions.
Responsible for monitoring and developing strategies to meet the timelines/milestones of the assigned multi-site clinical studies.
Work with USC Principal Investigators to ensure that the team at the study sites receive appropriate training to conduct USC IIT studies according to the approved protocol, current Good Clinical Practices governing clinical research and all applicable regulatory requirements.
Serve as a liaison between the industry sponsor and the study chair.
Work with DSMC and QAC to support the research operation strategic priorities to enhance communications and collaboration by supporting the implementation of best practices and tools for protocol execution, management and oversight as well as ensure protocol compliance, quality data collection.
Serve as an institutional resource to facilitate the management of INDs and FDA submissions.
Develop guidelines and tools to assist in protocol compliance and data collection.
Communicate the applicable regulations, and ICH guidelines, multicenter research best practice and specific protocol requirements with all participating sites.
Keep abreast of new internal and external developments related to the conduct and management of multicenter research
Serve as an institutional resource for the complete and correct application of federal regulations and industry best practices for the start-up and management of multicenter research.
Key Responsibilities include:
Lead the day-to-day operations of the Multi-site Coordinating Center in proactively identifying and implementing solutions to improve efficiency and timeliness of USC studies conducted at outside sites.
Facilitates communication between the study chair and the participating sites and ensure study compliance.
Reviews SOPs of participating site and communicate the site level practice for USC committees.
Identifies and communicates important study management issues to the study chair and CISO leadership.
Schedule and conduct teleconferences with the participating sites to provide trial updates and review patient and data entry status.
Responsible for disseminating all protocol related modification to all participating sites upon USC IRB approval.
Responsible for ensuring completion, collection, maintenance and management of all regulatory documents from the participating sites
Manages the reporting of the Unexpected and Related SAEs to the FDA and ensures that the report is shared with all the appropriate participating sites.
Facilitates the study drug shipment process with the participating sites.
Responsible for disseminating USC DSMC requests, deadlines and other relevant information to all participating sites.
Responsible for ensuring QAC selected audit cases are communicated with the participating sites and collect all required documents and/or access.
Ensures that all participating sites have system access to all systems required to complete data entry
Review and confirm invoices from the participating sites.
Performs other related duties as assigned or requested. The University reserves the right to add or change duties at any time.
The new Coordinator role will assume responsibility Â for Multi-site coordination and will work closely with investigators, Quality Assurance, Regulatory team Â and report to the Associate Director.
The University of Southern California strongly values diversity and is committed to equal opportunity in employment.Â Women and men, and members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply.
Preferred Education: Bachelorâs Degree; Combined experience/education as substitute for minimum educationPreferred Experience: Three years; Combined experience/education as substitute for minimum education
USC is the leading private research university in Los Angeles—a global center for arts, technology and international business. With more than 47,500 students, we are located primarily in Los Angeles but also in various US and global satellite locations. As the largest private employer in Los Angeles, responsible for $8 billion annually in economic activity in the region, we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills across a variety of academic and professional schools and administrative units. As a USC employee and member of the Trojan Family—the faculty, staff, students, and alumni who make USC a great place to work—you will enjoy excellent benefits, including a variety of well-being programs designed to help individuals achieve work-life balance.