Human Subject Research Spec I

University of RochesterRochester, NY
Onsite

About The Position

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. A Full-time position (40 hrs/wk) in Pediatric Infectious Diseases to conduct surveillance studies and clinical trials. In particular, this individual will be responsible for recruitment and administrative responsibilities for both gastroenteritis and respiratory infection surveillance studies under the direction of the Principal Investigator and Manager of Clinical Research. This individual will screen and recruit potential study candidates, and perform interviews, data and specimen collection, chart reviews, vaccine verifications, and data entry. This person must work well as part of a team, be able to complete project tasks independently as requested, be comfortable with a variety of data bases, and at all times demonstrate the ability to interact in a professional and positive manner in communications.

Requirements

  • Bachelor's degree required or Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required Or equivalent combination of education and experience
  • Candidate must become Human Subjects certified under the HSPP program within the first week of employment.

Nice To Haves

  • Word processing and data analysis software preferred

Responsibilities

  • Screening, recruitment, and monitoring of study subjects .
  • Screen eligible patients to make sure they meet enrollment criteria.
  • Explain study to parents and obtain informed consent.
  • Conduct study visits to ensure patient compliance with project protocol
  • Assist in developing recruitment strategies and monitoring target enrollment numbers.
  • Identification of subject pool and symptom preview
  • Information/specimen Management
  • Interviews with families as required by protocol
  • Collection, labeling, and coordination of study specimens to be delivered to the laboratory; ensure labeling is sequential and interfaces with lab labeling system.
  • Chart review and information abstraction/recording, phone communications with families/pediatricians/staff, fax/mail as necessary as pertains to enrolled subjects at your site.
  • Data entry and integrity checks: enter data into web-based database and respond to sponsor data queries as they arise.
  • Completion of source documents: CRFs, vaccine verifications, and 2-3 follow up phone calls for AGE cohort.
  • Attend team meetings and conference calls as needed
  • Interact with Project Coordinator and Research Lab Director to ensure regulatory and other documents are complete and on time.
  • Other duties as assigned.
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