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University of Rochester Health Project Coord - 225030 in Rochester, New York

Health Project Coord Job ID 225030

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 053 Radiation Oncology M&D

Schedule

8 AM-4:30 PM

Responsibilities

Position Summary:

To serve as Coordinator for clinical trials activities involving the University of Rochester Department of Radiation Oncology (DRO).

Responsibilities:

Under general guidance and with latitude for exercise of independent judgment, designs, implements, and maintains tools and database for use in the Departments clinical research studies and maintains regulatory documentation for the Department of Radiation Oncology clinical trials and studies. Assist with Subject Enrollment and the Completion of Case Report Forms.

Plan, implement, coordinate, administer and evaluate clinical research studies, including NCI sponsored, Industry sponsored, and Principal Investigator trials for cancer patients and cancer survivors. Maintain a working knowledge of the area of expertise by reviewing research literature and abstracts, attending pertinent local and national meetings and seminars.

Serves as liaison between study personnel, investigators, hospital staff, patients and their families in all phases of studies. Plan and execute required aspects of the research project working with the PI, the Clinical Trials Office, the Research Subjects Review Board (RSRB), physicians and other health care professionals which may include, but are not limited to, the following:

Maintenance of Regulatory Documents

  • Complete and submit proper study documentation to the RSRB, NRG or any other applicable agency. Write and prepare consent forms, prepare adverse event reports of assigned studies for review and submission to the IRB, the FDA, and any other required agency.

  • Provide ongoing education and information to all providers and other research staff, regarding developing protocols and current research.

  • Assist with the study audits conducted by independent monitors and federal and governmental agencies or RSRB.

  • Keep informed of protocol availability and addenda/ changes.

  • File regulatory documents with appropriate organizations such as the Clinical Trials Support Unit (CTSU), RSRB, WRB, IROC.

  • Assist with obtaining Radiation Therapy Pre-Registration requirements, including phantoms and bench marks.

    Design, Implement, and Maintain Tools and Databases For Use in the Department’s Clinical Research Studies

  • Be familiar with standard operating procedures, and verify data ensuring compliance with requirements of the protocol and federal regulations

  • Assist with screening and identifying potential study patients, completing case report forms, completion go QOL and Neurocog assessments, and maintenance of patient data, such as, consent forms, letters, and appointment notices

    Qualifications:

    Bachelor's degree with major course work in an appropriate health, social or technical field and 2-3 years (3-5 preferred) of related experience; or an equivalent combination of education and experience.

    Preferred Qualifications

    Professional Research Certification (ie. SOCRA or ACRP) is preferred. Excellent verbal and writing skills are preferred. Proficiency in the use of computer databases, word processing, and spreadsheets is preferred.

    How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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