This position has an end date of 7/1/2024
Coordinates the administrative activities associated with conducting health and technology-related research studies. May assist Principal Investigator in conducting clinical studies, and in presenting study research results. Interacts with study sponsor and partners on research projects.
Coordinates the administrative activities necessary for clinical studies such as maintaining protocol and PI brochures for relevant study team members, preparing materials for study visits, drafting and maintaining informed consent documents and the scope of work specific to projects and preparing study materials for study visits. Under general direction from the Principal Investigator (PI), trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, 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 devices. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to. Develops independent research projects utilizing technology aimed at improving health globally.
Develops recruitment strategies and targets. Recruits and consents participants for research studies. Recruits and screens patients by reviewing study sites’ patient database and/or office records for potential study candidates that meet the proposed protocol criteria. Conducts telephone screenings of patients in order to identify potential study candidates.
Conducts remote and/or in-person assessments of research participants. Manages study visits to ensure patient compliance with protocol activities, and to ensure that all data is collected and secured within determined parameters and procedures. Ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review. Communicates adverse events to the PI, documents them as advised and reports them to Institutional Review Board (IRB), Sponsor, and/or any other required recipients.
Disseminates research findings by drafting abstracts, presentations, and publications for peer review and industry forums. 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. Keeps current with industry standards, best practices, trends in therapeutic areas relevant to research studies; makes recommendations and implements changes as appropriate. Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e. pre-study inspection, initiation, on-going and close out visits). Follow Research Subject Review Board regulations and complete application paperwork, meet reporting requirements, and ensure compliance with institution and other regulatory agency requirements.
Other duties as assigned
Bachelor’s Degree required
Equivalent cominbation of education and experience e.g. an Associate’s degree and completion of 6 months in the Human Subject Research Coordinator Trainee program preferred.
2 years’ experience in clinical research coordination or technology research or equivalent combination of education and experience
Knowledge of word processing and spreadsheets preferred.
Strong attention to detail and excellent interpersonal and communication skills.
CITI certification 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
Opening: Full Time 40 hours Grade 051
Schedule: 8 AM-5 PM; OCC WKENDS