MGR, Clinical Research

Benefits

Qualifications

• •Masters degree in appropriate area of specialization; or a bachelors degree in appropriate areas of specialization and two years of experience
• •Masters degree in appropriate area of specialization; or a bachelors degree in appropriate areas of specialization and two years of experience
• •Have a PhD
• •Previous experience in working with agencies involved in organ donation and procurement and a general understanding of the processes underlying the operations of such organizations
• •Prior responsibility for negotiating numerous financial and legal contracts and budget oversight
• •Extensive experience working with CEOs and Executive Directors of both not-for-profit and for-profit enterprises
• •Great communicator with internal contacts, PIs, division chiefs, chairs,, and internal staff members
• •Application must be submitted by 11:55 p.m. (ET) of the posting end date
• •5 more items(s)

Responsibilities

• •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: Serve as nPOD liaison for Data Portal , including working with Data Core
• •Oversee the development of new IT system related the nPOD data deposit and presentation
• •Provide direction to the IT development team on integrating various nPOD data platforms to support nPOD staff, investigators, and partner organizations
• •Implement online opportunities for data sharing and collaboration by nPOD investigators
• •Serve as Administrative Core liaison for the nPOD and CaRe-T1D public-facing websites to improve functionality and usability
• •Partner with the UPenn subcontract team in building the new Data Science Portal to host and share data generated by CaRe-T1D and investigators
• •Assist in backend database design and testing; oversee implementation of the new system
• •Investigator Relations: Hire, train, and assist the Investigator Coordinator to support and manage relationships with investigators from initial contact throughout the project completion
• •Oversee investigator-related activities to ensure outstanding customer service for the nPOD and CaRe-T1D programs
• •Recruit investigators through scientific conferences and literature searches
• •Foster relationships with and provide support to nPOD investigators recruited from industry
• •Write letters of support for investigators as requested
• •Assist investigators with IRB paperwork at home institution
• •Oversee the development and dissemination of investigator-focused online newsletters to investigators, including new nPOD and CaRe-T1D initiatives and activities
• •Form and facilitate new working groups, including recruiting investigators and setting up calls and webinars
• •Determine need and topics for webinars, as approved byprogram sponsors
• •Maintain compliance with nPOD and CaRe-T1D publications policy and assist with proper implementation of nPOD and CaRE-T1 nomenclature
• •Develop, maintain, update and administer nPOD and CaRe-T1D Material Transfer Agreements (MTAs), and provide guidance on MTA-related issues for program investigators
• •Coordinate the legal aspects of obtaining human biospecimens and images from other type 1 diabetes biobanks into the nPOD collection
• •Work with collaborators to create and manage the nPOD and CARE-T1D publication tracking system to more accurately capture publications utilizing nPOD and CaRe-T1D resources
• •Personnel management, including on-call scheduling, recruitment, hiring, training, supervision, and annual personnel evaluations
• •Participate in on-call-scheduling by evaluating organ donors to fit the program needs
• •Annual Meetings: Lead the administrative team to organize annual scientific meetings, helping the Executive and Co-executive Director plan and execute successful investigator meetings
• •Report program progress and utilization at meetings and in manuscript format suitable for publication, as well as note grant progress reports and applications
• •Present the nPOD and CaRE-T1D program progress to their respective leadership (both internal and with SABs)
• •Develop conceptual project design for new grant opportunities and participate in grant writing
• •Determine the experimental process and data analysis methodology with reporting of results to senior management
• •Assist in securing funding and expanding research programs that leverage existing organ procurement and processing infrastructure, as well as existing nPOD and CaRe-T1D biobanks
• •38 more items(s)