University of Rochester Human Subject Res Coord I in Rochester, New York

Opening

Full Time 40 hours Grade 051 Pediatrics M&D; Inf Diseases

Schedule

8 AM-4:30 PM; EVENINGS AND WEEKENDS AS NEEDED; SCHEDULE WILL VARY BASED ON OPERATIONAL NEEDS.

Responsibilities

THIS POSITION HAS AN END DATE OF 9/29/18.

Overview:

This full-time position is for a candidate who will work under the direction of the Principal Investigator (PI) and Human Subject Research Coordinator II (HSRCII) in the Division of Pediatric Infectious Diseases, to provide study coordination services for NIH/CDC funded human subject research. The position assumes some latitude for autonomy and requires a degree of independent judgment. The successful candidate will be responsible for helping create, revise, and implement study protocols; identify and obtain informed consent from pediatric research subjects; and act as a resource for research subjects and their families. The candidate will be expected, as studies warrant, to interface with the study sponsor, with personnel of other sites (by teleconference call and/or electronic mail, for multi-center sponsored studies) and travel to other local study sites (community MD offices and local hospital) for subject medical record review. The candidate will maintain continuous communications with the study team and Principal Investigator, and may be asked to assist with collection of summary data for IRB submissions. The ability to develop and maintain good clinical practices and to deliver safe and thorough research subject care is a must, as is the demonstration of ICARE* values.

Local travel is required. Must have reliable/efficient transportation. Full Time 40 hours per week, usually weekdays, daytime hours; occasional evenings and weekend days may be required depending upon study priorities.

Major Responsibilities:

Coordination of Human Subjects Research

  • Assist with the development of study designs and study specific documentation (consent forms, data collection sheets, etc.) for review by Principal Investigator and research team.
  • Independently coordinate the implementation of research studies. Work with Principal Investigator and Human Subject Research Coordinator II to establish study start-up and perform ongoing maintenance of study protocols and forms. Communicate with other multi-center study sites on study progress/problems by teleconference call and electronic mail.
  • Develop recruitment strategies for appropriate full enrollment. Troubleshoot problems in enrollment and continuation of study procedures, and develop solutions, in conjunction with the Principal Investigator and the HSRC-II.
  • Identify subject pool and preview symptoms which may lead to appropriate Study Inclusion.
  • Confirm study eligibility of pediatric subjects, utilizing Inclusion/Exclusion Criteria; explain the study to subject/family and obtain informed consent, and as applicable, obtain child/adolescent assent.
  • Enroll the subject into the appropriate study. Track and ensure that subject enrollment goals are met and all study measures are collected. Explain appropriate study-required samples (such as blood/stool/nasal-throat swab specimens) to subjects/family; obtain and deliver specimens appropriately (e.g., at room temperature, on ice pack, etc. as per interpretation of protocol requirements) to the research laboratory.
  • Act as information resource to research team and sponsor for protocol-specific queries, logistical questions (e.g., eligibility questions, which protocols are open to enrollment, general knowledge of protocol status).
  • Identify study related issues and propose resolutions to Principal Investigator and HSRCII.

  • Data & Information Management*

  • Ensure timely and accurate completion of study documents (Informed Consent, Clinical Research Forms, study specific databases) required by study sponsor and regulatory bodies; become proficient on required reporting databases.Maintain organized documentation, including enrollment forms, eligibility checklists, adverse event reporting forms, and Case Report Forms, study and regulatory binders, etc. for review by sponsor and study monitors.

  • Prepare and submit travel logs.

Requirements:

Bachelor’s degree and 1 year of experience in human subject research coordination; or equivalent combination of education and experience. Knowledge of word processing and data analysis software preferred. Prefer 2 years of experience in human subject research coordination.

This individual must be organized, hard-working, and able to work as a team member as well as independently. Must possess excellent and effective communication, organization and decision-making skills and maintain accurate and complete records on all subjects for sponsor review. Must be able to prioritize tasks and be comfortable handling confidential information. Must be able to and willing to provide or assist in study procedures such as obtaining blood/stool/nasal-throat swab specimens and collecting subject data.

At a local level, this individual must have the ability to devise the necessary strategic methods required to assure the success of the research projects and the ability to interact effectively with a wide range of individuals including subjects, staff, and clinical researchers at all levels.

Pediatric clinical research experience is a plus. Candidates must possess strong computer skills, excellent communication skills, telephone skills, and ability to work in a multi-faceted team environment. A licensed practical nurse (LPN), radiology technician (XRT) or a patient care technician (PCT) would be considered. Candidates must demonstrate the desire and initiative to increase knowledge and skills in the clinical research field and keep current in areas relevant to current sponsored studies.

Local travel is required. Must have reliable/efficient transportation. Full Time 40 hours per week, usually weekdays, daytime hours; occasional evenings and weekend days may be required depending upon study priorities.

EOE Minorities/Females/Protected Veterans/Disabled

Job Title: Human Subject Res Coord I

Location: School of Medicine & Dentistry

Job ID: 201382

Regular/Temporary: Regular

Full/Part Time: Full-Time