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University of Rochester Human Subject Research Coordinator I - 236615 in Rochester, New York

Human Subject Research Coordinator I Job ID 236615

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

Part Time 20 hours Grade 051 Medicine M&D-Nephrology Div

Schedule

8 AM-4 PM

Responsibilities

Position Description:

Coordinates the activities associated with human subject research. May supervise others.

Responsibilities will include:

  • Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.

  • Conducts visits to ensure research participant adherence with protocol requirements such as taking of medications, proper use of device, and/or other interventional activities; to document adverse events and report to senior study staff, Principal Investigator (PI), Institutional Review Board (IRB), Sponsor and/or any other required recipients or entities; and to ensure all data are collected and secured within approved parameters and procedures.

  • Coordinates the administrative details required to initiate and conduct human subject research, such as, receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials (i.e., brochures, advertisements, newsletters, etc.) to immediate team members and relevant others. Liaising with study sponsors as applicable.

  • Reviews and documents the dispensing and returning of study materials (such as study drugs and devices). Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to

  • Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines, and makes recommendations. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keeps current with industry standards, best practices, trends in therapeutic areas relevant to research studies; makes recommendations and implements changes as appropriate

  • Ensures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures and standards for documentation and communication. Under general direction from the Principal Investigator, trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and case report form (CRFs) completion, and adverse event reporting.

    Other duties as assigned.

    Requirements:

  • Bachelor's Degree required

  • 1 year of experience in human subject research coordination or equivalent combination of experience and training required

  • Prefer a degree in marketing, communications, life sciences, health administration or a related discipline as well as prior clinical research experience. Proficiency in computer software applications including Microsoft Office programs such as Excel, Outlook, and Word. Ability to learn and master existing department applications and future software applications and programs. Excellent communication, interpersonal and organizational skills; highly persistent and energetic professional style; self-motivation and drive to reach goals/objectives. Strong attention to detail, ability to digest and understand the study, and the strong ability to use good judgment in assessing each individual’s comprehension preferred

    The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

    How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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