Human Subject Res Coord II
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 respiratory illnesses such as influenza and COVID19, phase 1-3 vaccine studies, studies in therapeutic agents in both adult and pediatric 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.
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 and visits conducted under stringent precautions.
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.
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.
Trains research coordinators and other staff about activities associated with conducting human subject research 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 disease of respiratory pathogens such as COVID19, Influenza and RSV.
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.
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.
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.
Other duties as assigned.
Bachelor’s degree required
And 3 years of experience in human subject research coordination; or an equivalent combination of education and experience required.
Experience as Human Subject Coordinator I preferred
Knowledge of word processing and data analysis software.
Experience as a Human Subject Research Coordinator.
2-3 years of clinical research experience
Independent and organized professional with superior interpersonal skills, sound judgment and good oral and written communication skills.
Professional Research Coordinator Certification (i.e., SoCRA or ACRP)
Nursing Degree – RN or other advanced degree pertaining to clinical or healthcare research
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
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 053 Medicine M&D-Infect Dis Unit
Schedule: 8 AM-4:30 PM; AS NEEDED