Human Subject Res Coord II
This is a position in the Pediatric Infectious Division to serve as a lead coordinator in pediatric clinical and translational studies, including studies of pediatric COVID-19 vaccines. This person will spearhead study recruitment efforts and will work directly with the PI and the team lead on clinical trials. Responsibilities will include independently maintaining regulatory paperwork, interacting with the representatives of the study sponsor and study monitors, screening and recruiting subjects, performing informed consenting and interviews, completing study safety calls, performing data entry, and completing medical chart reviews. He/she will ensure thorough understanding of study protocols, communicate clearly with families, study sponsors, and regulatory authorities, respond to questions that arise during the study, communicate regarding and document adverse events as advised by the Principal Investigator, and ensure regulatory and other documents (such as consent forms and CRFs) are complete, accurate and available for review.
Oversees and coordinates human subject research activities. Participates in the planning, development, and implementation of a clinical trial, including study design, budget development, protocol development, development of appropriate consent and assent forms, and the manual of procedures and site-specific SOPs.
Develops, implements and evaluates recruitment strategies to ensure successful trial recruitment. Will work with sponsor representatives and University marketing to design relevant recruitment materials. Will perform medical chart review, screen patients to ensure enrollment criteria are met and explain the study to potentially eligible families.
Conducting study visits and safety calls with subjects, including interviews and obtaining informed consent. Documents and reports adverse events to the investigators, IRB, and sponsor
Develops, implements, and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. Reviews study progress, including data inputting, documentation review, and reporting deliverables. Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression.
Trains research coordinators and other staff on activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements.
Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines. Demonstrates accountability for continuous learning in accordance with GCP guidelines. Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies and designs.
Implements and monitors resulting study changes.
Other duties as assigned
Bachelor’s Degree or equivalent experience required
3 years of experience in human subject research coordination or equivalent combination of education and experience required
Experience as Human Subject Research Coordinator I preferred
Ability to work effectively with children and families. Flexible in approach and appreciates the demands of a fast-paced, constantly evolving project required.
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 Pediatrics M&D Inf Diseases
Schedule: 8 AM-4:30 PM