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University of Rochester Human Subject Res Coord II - 230169 in Rochester, New York

Human Subject Res Coord II Job ID 230169

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

Full Time 40 hours Grade 053 Medicine M&D-Infect Dis Unit

Schedule

8 AM-4:30 PM

Responsibilities

GENERAL PURPOSE:

The position is to join a dynamic and very busy research clinic with multiple contracts with the NIH and pharmaceutical companies. Studies currently being conducted include observational studies of respiratory illnesses such as influenza and COVID19, phase 1-3 vaccine studies, studies in therapeutic agents in both adult and pediatric populations. Applicants should be able to work with a variety of subjects and have clinical research experience and under general direction and with latitude for independent judgment assume full responsibility for various clinical projects as outlined below.

RESPONSIBILITIES:

  • Participate in performing all protocol required study procedures on subjects which include but are not limited to nasal swabs, nasal washes, venipuncture, urine collection. Review and interpret study guidelines for next steps necessary for the processing and/or shipment of samples. This may require home visits and visits conducted under stringent precautions.

  • Participate in the recruitment of adult study subjects; contacting potential study participants who have expressed preliminary interest, collecting the necessary data to initiate the study visit, perform informed consent procedures: screening of potential subjects for inclusion/exclusion criteria including obtaining Informed Consent.

  • Facilitate daily coordination of clinical trial activities for the infectious disease research clinic including but not limited to disease of respiratory pathogens such as COVID19, Influenza and RSV.

  • Participate in the reporting of subject serious adverse events (SAE) and filing of these in a timely manner to sponsors and IRBs.

  • Collect and maintain subject data into designated subject databases and managed regulatory binders for assigned studies. Participate in entering the study data into appropriate data, ensuring all data meets study specific requirements.

  • Contribute to the design of the study protocol processes including the development and maintenance of standard operating procedures; design study data entry forms; assist senior Human Research Subject Coordinator with preparation of regulatory documents.

  • Conduct quality checks and prepare documents for and participate in external monitoring visits. Assist with communication with regulatory bodies including the NIH and pharmaceutical sponsors.

  • Other duties as assigned.

QUALIFICATIONS:

  • Bachelor’s Degree required.

  • And 3 years’ experience in human subject research or an equivalent amount of education and experience in a clinical field. Experience as Human Subject Research Coordinator I required.

  • Knowledge of word processing and data analysis software preferred.

  • Professional Research Coordinator Certification (i.e., SoCRA or ACRP) preferred. Independent and organized professional with superior interpersonal skills, sound judgment and good oral and written communication skills highly preferred.

    How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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