The UHEI Reading Center Coordinator Lead oversees the management of the data and input for the UHEI Reading Centers via oversight of the program coordinators. The UHEI Reading Center Coordinator Lead will manage reading center-related aspects of multi-center clinical trials including coordination of reading center staff and regulatory documents for the reading centers in accordance to the Reading Center SOPs. They will also manage study site certifications, study data and study image receipt, and manage the processing of the images through the grading and reporting process. The position is a subject matter expert on the regulatory requirements specific to Clinical Trials. Leads will focus on innovation and best practices for compliance in these programs. The UHEI Reading Center Coordinator Lead will be responsible for the operational oversight and productivity their respective projects/contracts program coordinators.

What You Will Do

• Complete administrative support for reading center studies including monitoring of regulatory standards. Create studySpecific site manuals and project plans. Ensure that all regulatory compliances are met, appropriate IRB submissions aremaintained and all data collection is accurate. Maintain study specific regulatory binders. Facilitate inventory, readings, datatransfers and archiving of study materials. (25%)
• Facilitate image processing (includes image receipt, quality check of images, confirmation of absence of PHI,Assignment of image grading and transfer of study data). Facilitate resolution of queries related to incomplete or unacceptable study or certification image submissions; or discrepant or missing information related to those submissions. (25%)
• Maintain inventory and documentation related to receipt of study/certification images and materials, as well as queryResolution and other correspondence. Maintain a log of all study images read. (25%)
• Administrative oversight of the operational performance of assigned program coordinators. The Leads will take responsibility of assigned projects/contract and provide regular updates to the Reading Center leadership in regards to task completion and staffing needs and productivity. (25%)

Additional Responsibilities

• Performs other duties as assigned.
• Complies with all policies and standards.
• For specific duties and responsibilities, refer to documentation provided by the department during orientation.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.