MGR, Clinical Research

Classification Title:

MGR, Clinical Research

Job Description:

Overall Programmatic Strategy and Management: Create and implement the overall strategic plan for nPOD, CaRE-T1D, and other related projects that arise, including organ recovery, screening laboratory participation, internal systems (intranet), external systems (internet, web-based data management systems), and legal and regulatory affairs. Oversee internal relations, hiring, and staff development and training. Maintain budgets and provide forecasting. Create, implement, and oversee the marketing and communications strategy. Create a strategic plan for Organ Procurement Organization (OPO) outreach and partnerships and provide leadership and oversight to all administration and operation activities, space, equipment, and budget. Manage overall grant activities, including (and especially) newly awarded efforts. Manage the external SAB and Executive committees for these programs. Work closely with grant manager on budgeting, expenses, and sub-awardee activities.

Organ Recovery: Create and maintain partnerships with procurement organizations (OPOs, NDRI, IIAM), screening labs, other organizations, and internal departments at UF. In collaboration with Contracts & Related Services and the General Counsel’s Office, negotiate contracts with laboratory CEOs/CFOs; audit compliance of contractual obligations. Serve as on-call representative for cases referred by NDRI, IIAM, or OPO partners. Assess referrals for donor suitability. Ensure that the associated projects conform to current best practices and comply with all regulatory and FDA requirements for human biospecimen recovery and distribution and HIPAA.

Data and Regulatory Management and Integration: Oversee IT systems development related the nPOD intranet and data management systems. Provide direction to the nPOD assistant director and administrative assistant on how to integrate data systems. Implement an intranet interface for nPOD staff, investigators, and partner organizations. Implement online opportunities for data sharing and collaboration by nPOD investigators. Maintain and update nPOD website for improved functionality and usability. Serve as nPOD liaison for DataShare, including working with Data Core. Serve as Administrative Core liaison for the website.

Set up and manage Constant Contact for mailing lists for various marketing campaigns: Work with DataShare programmer on project management, including investigators, Co-investigators, applications, addenda, IRB, MTA, and more. Work closely with the Data Scientist and OPPC Director on Data Science initiative to replace DataShare. Partner with the UPenn subcontract team in building the new Data Science Portal to host data generated by nPOD COREs and investigators. Similarly, work closely with the CaRE-T1D data management team located in UPenn to develop the CARE-T1D database and public facing website.

Investigator Relations: Hire, train, and assist the Investigator Coordinator to manage relationships with investigators from initial contact throughout the project. Oversee investigator-related activities to ensure the nPOD team's outstanding customer service. Recruit investigators through scientific conferences and literature searches. Foster and assist nPOD investigators recruited from industry scientists. Write letters of support for investigators as requested. Assist investigators with IRB paperwork at home institution. Create and deliver relevant online newsletters to investigators, including new nPOD developments. Supervise all investigator application and addendum processes, including communication with Tissue Prioritization Committee (TPC) prior to project approval. Ascertain investigator interest in tissue needs. Coordinate administrative aspects of new investigator-related projects, including compliance with regulatory and legal requirements, logistics, and start-up assistance. Manage all investigator-based committees. Coordinate with committee leaders for committee functions. Organize existing Working Groups on project progress. Form and facilitate new nPOD working groups, including recruiting investigators and setting up calls and webinars. Determine need and topics for webinars, as approved by JDRF. Create and deliver relevant online newsletters to investigators, including new nPOD and CARE-T1D developments. Oversee the Abstract process for the nPOD Annual Meeting: call for submissions, late-breaking deadlines, present to the Review Committee, notify applicants, and assist with meeting agenda to accommodate presentations. Plan and manage Poster Sessions at the nPOD Annual Meeting. Maintain compliance with nPOD publications policy and assist with proper implementation of nPOD and CaRE-T1 nomenclature. Partner with the OPPC Manager to ensure investigator service requests are eligible for fulfillment. Develop