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 have clinical research experience and under general direction and with latitude for independent judgment assume full responsibility for various clinical projects as outlined below.
Contribute to the design of the study protocol. Prepare documents for new studies, amendments and annual reviews for studies for submission to the University Research Subjects Review Board (RSRB) protocol or the NIH; assist senior Human Research Subject
Coordinator with preparation of regulatory documents
Participate in the recruitment of adult study subjects; contacting 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.
Track and prepare requests for payments to subjects.
Participate in performing 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.
Collected and maintained 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.
Discuss with subjects’ potential adverse events and SAEs and participating in grade of events. Participate in the reporting of subject serious adverse events (SAE) and filing of these in a timely manner to sponsors and IRBs.
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.
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.
Other duties as assigned.
Bachelor in Nursing required
Masters in Nursing or related field preferred
1-year clinical research experience
An equivalent combination of education and experience required.
Phlebotomy skills for adult and pediatric patients and good computer skills required.
Independent and organized professional with superior interpersonal skills, sound judgment and good oral and written communication skills required.
RN licensure required
Ability to complete the Collaborative Institutional Training Initiative (CITI) program as well as other study specific training & certification required.
Spanish language skills 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
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time