MGR, Clinical Research

Apply now Job no: 538421
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Grant or Research Administration
Department:29080100 - MD-PATHOLOGY-GENERAL

Classification Title:

MGR, Clinical Research

Classification Minimum Requirements:

Masters degree in appropriate area of specialization; or a bachelors degree in appropriate areas of specialization and two years of experience.

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: 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
Expected Salary:

Commensurate with education and experience

Required Qualifications:

 

Preferred:

Have a PhD.

Previous experience in clinical research highly preferred.

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
Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume.

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

Health Assessment Required: Yes

 

Advertised: Eastern Standard Time
Applications close: Eastern Standard Time

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