University of Rochester Human Subject Res Coord II - 222552 in Rochester, New York
Human Subject Res Coord II
School of Medicine & Dentistry
Full Time 40 hours Grade 053 Medicine M&D-Infect Dis Unit
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 COVID19, phase 1-3 COVID vaccine studies and ongoing HIV vaccine research. Studies in therapeutic agents in adult 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.
20% Administers 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, visits on a mobile unit and visits conducted under stringent precautions.
20% Organizes the recruitment of adult study subjects; screen 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.
15% Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression. 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. Oversees training for matters related to studies.
15% Creates and collects required documents for IRB submission as well as study start up. This includes tracking of all documents through the initial process and monitoring and implementing change as need throughout the study specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements. Facilitate daily coordination of clinical trial activities for the infectious disease research clinic including but not limited to COVID19, HIV research.
10% Develops, implements and monitors systems and methods to ensure quality, safety, efficiency, and consistency in the processing of human subject research data. Contribute to the design of the study protocol processes including the development and maintenance of standard operating procedures; design study data entry forms
10% 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.
5% Ensures the integrity and security of all study data at all times. Initiates, monitors and ensures that all protocol activities are standardized across study sites. Implements immediate and appropriate corrective action when inconsistency of activities is identified. Ensures compliance in the reporting of subject serious adverse events (SAE) and filing of these in a timely manner to sponsors and IRBs.
5% Perform other job duties as needed/assigned.
Bachelor’s degree and 3 years of experience in human subject research coordination; or an equivalent combination of education and experience. Knowledge of word processing and data analysis software. Professional Research Coordinator Certification (i.e., SoCRA or ACRP) preferred. Experience as Human Subject Research Coordinator I preferred.
Preferred additional requirements: Nursing Degree – RN or other advanced degree pertaining to clinical or healthcare research, 2-3 years of clinical research experience. Independent and organized professional with superior interpersonal skills, sound judgment and good oral and written communication skills.
NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled