University of Rochester Human Subject Res Coord I - 218245 in Rochester, New York
Human Subject Res Coord I
School of Medicine & Dentistry
Time as Reported Grade 051 Medicine M&D-Nephrology Div
8 AM-4:30 PM
Coordinates the activities associated with human subject research. May supervise other.
Under general direction within policy guidelines and approved procedures and protocols:
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.
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 for 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.
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.
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.
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, and trends in therapeutic areas relevant to research studies; makes recommendations and implements changes as appropriate.
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 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
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled