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University of Rochester Sr Health Project Coord - 226521 in Rochester, New York

Sr Health Project Coord Job ID 226521

Location

School of Medicine & Dentistry

Full/Part Time Full-Time

Favorite Job

Regular/Temporary Regular

Opening

Full Time 40 hours Grade 055 Medicine M&D-Infect Dis Unit

Schedule

8 AM-4:30 PM; WKND AS NEEDED

Responsibilities

Position Summary:

The Senior Health Project Coordinator (Sr HPC) is a member of the Infectious Diseases Division and will serve as the assistant administrator of the Vaccine Research Unit (VRU). A high degree of initiative, leadership and the ability to deal with the complexities of working with study sponsors, governmental entities, study participants and professionals is necessary. Supervisory, organizational and management skills will be especially important in helping assume responsibility for the operations of the Vaccine Research Unit and oversight of an extensive range of government (NIH), investigator initiated and industry sponsored vaccine and antiviral clinical trials. The Sr. HPC will independently anticipate, identify and solve problems in promoting smooth operation of all aspects of the Vaccine Research Unit. Demonstrates ICARE* Values in each of the major responsibilities.

Responsibilities:

Directs the planning, implementation, coordination, operation and evaluation of the Vaccine Research Unit:

  • Under guidance of the Investigators and the Administrator of the VRU, will determine the feasibility of study protocols with the investigators and sponsors and will implement said studies: this includes review of the protocol requirements and creation of the Informed Consent forms.

  • Responsible for interaction with research pharmacy and execution of pharmacy protocol requirements,

  • Develops and completes regulatory submissions both initial, amendments and annual reports to IRBs and other research agencies.

  • Identify and develop a recruitment plan and the necessary recruitment material; maintains and evaluate the plan; ensures that all studies remain in good standing and maintain appropriate accrual levels.

  • Develop and oversee regular auditing/quality assurance processes for active studies, ensuring compliance for data entry and reporting requirements, Good Clinical Practice and safety principles.

Provides professional direction within the project. Maintains a working knowledge of the area(s) of expertise by reviewing research literature and abstracts, attending pertinent meetings and seminars.

  • Provides supervision and training for both URMC regulatory standards and sponsor protocol requirements to a team of Project Nurses, Data Clerks and other support staff. Attends and leads, as needed, weekly team meetings. Attends Site Selection Visits, Site Initiation Visits, and Sponsor Monitor visits.

  • Establishes and develops guidelines for distribution of expenses. Assists Division Administrator in the preparation of the sponsor budget and oversees the monitoring of expenses for studies and reviews financial reports based on the cost factors of the project:

  • Reviews the protocol with investigators and sponsors to assist the Administrator in the development of study budgets and timelines based on protocol specific requirements. Provides administrator/division accountant with information to create invoices for study payments.

Additional duties as needed:

  • Assess study subjects and perform study procedures including nasal wash/aspirate, and blood drawing on adult and pediatric study subjects as needed

  • Organize inventory, supplies and charts for each individual study protocol; oversees the protocol required data entry, filing, mailings, source document development and compiling study summary data.

  • Prepares analytical reports and recommendations for publication or grant requests.

  • Prepares information required for annual reports and enrollment tables

Ages of population served: Infant - 80+

Qualifications:

Bachelor's degree with major course work in an appropriate health, social or technical field, 3-5 years of related experience; or an equivalent combination of education and experience.

Preferred Qualifications

LPN or RN Licensure, Clinical Research Coordinator Certification, computer skills; phlebotomy (pediatric phlebotomy a plus)

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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