Project Manager II- Department of NeurosurgeryCAPTIVA StudyApply now (https://secure.dc4.pageuppeople.com/apply/674/gateway/default.aspx?c=apply&lJobID=533102&lJobSourceTypeID=796&sLanguage=en-us) Job no: 533102 Work type: Staff Full-Time Location: Main Campus (Gainesville, FL) Categories: Grant or Research Administration Department: 29190000 - MD-NEUROLOGICAL SURGERY Classification Title:Project Manager II-CAPTIVAJob Description: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 AdministrationLead administrator of $38 million NIH grant and implementation of tracking mechanisms to facilitate detailed, line-item cost analysisManagement 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 invoicesPreparation of all required NIH reports related to CAPTIVA (e.g., annual Progress Reports, Administrative Continuation Reports, Carryover requests, etc.)Regulatory AdministrationPrepare 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 toolsRetain records/archive documents during and after project close-out, including oversight of protocol versioningExpected Salary:$92,200-$103,100Minimum Requirements: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.Preferred Qualifications:
Licensure as a registered nurse
Professional certification through ACRP, SOCRA, or similar clinical research organization
Experience with coordination and/or management of multi-site clinical trials
Experience coordinating endovascular, neurological, and/or stroke clinical trials
Special Instructions to Applicants:For consideration, please complete an application and include a cover letter, resume and the names and email addresses of three to five references. The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Application must be submitted by 11:55 p.m. (ET) of the posting end date.Health Assessment Required:NoAdvertised: 12 Sep 2024 Eastern Daylight TimeApplications close: 19 Sep 2024 Eastern Daylight Time