Project Manager II-CAPTIVA

CAPTIVA Project Management

• Manage project timelines and foster relationships with approximately 100 study sites across the United States, ensuring seamless communication and collaboration.
• Provide comprehensive support to study sites by responding to emails and phone inquiries within 24 hours, and effectively triage issues to the appropriate team experts.
• Schedule and conduct site readiness training sessions, ensuring accurate documentation.
• Develop content and deliver monthly educational webinars and newsletters to site coordinators and investigators, ensuring ongoing communication and education.
• Participate in StrokeNet committees, meetings, and webinars, representing project interests.
• Monitor site performance metrics and implement corrective actions when necessary to maintain project standards.
• Coordinate the shipment of specimens and imaging collections/transfers, assisting CAPTIVA core entities and sites as needed.
• Facilitate study-wide communication of key information, including protocol amendments, trial updates, and reminders, through newsletters and other channels.
• Participate in Operations and Executive Committee conference calls, overseeing the documentation and distribution of meeting minutes.
• Supervise the preparation and dissemination of reports, promotional materials, and publications, ensuring consistency and accuracy.
• Ensure adherence to Good Clinical Practice (GCP) standards across all study sites and coordinating centers.
• Develop and implement standards and best practices for the Clinical Coordinating Center and study sites to ensure protocol compliance.
• Plan, organize, and execute the virtual annual Investigators Meeting, ensuring smooth event coordination.

Grant Administration

•Lead administrator of $38 million NIH grant and implementation of tracking mechanisms to facilitate detailed, line-item cost analysis

•Management of multiple subcontracts and internal projects for CAPTIVA collaborators and Co-Investigators (for example, the National Coordinating Center and Imaging Management Center at UC, National Risk Factor and Data Management Center at MUSC, and the Medical Monitor at SUNY)

•Oversite of UF Finance and Grants Accounting efforts to ensure timely payment to sites for their effort of these collaborators and the review and processing of invoices

•Preparation of all required NIH reports related to CAPTIVA (e.g., annual Progress Reports, Administrative Continuation Reports, Carryover requests, etc.)

Regulatory Administration

•Prepare and submit study documents to the appropriate committees (IRB, DSMB, etc.)

•Develop and revise study documents including, but not limited to, protocol revisions, informed consent updates, summaries of changes, manual of procedures, study materials and tools

•Retain records/archive documents during and after project close-out, including oversight of protocol versioning

$92,200-$103,100

Master's degree in in an appropriate area; or a bachelor's degree and two years of relevant experience; or an equivalent combination of education and experience.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.