Human Subject Res Coord II
The main duties of this individual will be to participate in protocol and consent form development, budget development, negotiation and implementation, discussions with the human subjects review board and the University's legal office, ensuring compliance with protocol procedures. They will have responsibility for overseeing administrative processes related to human subject research, maximizing efficiency in human recruitment, enrollment, and follow-up of volunteers while meeting regulatory, University and sponsor requirements for the projects. Other duties include data analysis, preparing reports on specific trials, and appropriate close out of clinical trials that are complete. May include travel to study sponsor meetings and/or travel off-site to consent and/or collect specimens/samples.
Provide professional direction for assigned projects. Organize and plan project start up, including applying for IRB, GCRC, and IBC approvals. Prepare documents for regulatory agencies including WIRB, RSRB, GCRCC, and FDA. Prepare reports including IND applications and those for FDA and IRB. Assist in design of protocols. Assist in preparation of grants for submission to government agencies.
Act as a point person for all assigned studies when Principal Investigator(s) are not available. Use clinical judgment in reviewing labs and adverse events and reporting them appropriately. Prepare serious adverse event reports.
Code data for purposes of data entry. Review and respond to data queries. Maintenance and protection of patient data.
In conjunction with Supervisor/Principle Investigator(s), prepare and maintain budgets.
Coordinate efforts of collaborating investigators. Assists Principle Investigator(s) with training to assure compliance. Represent our Center at appropriate meetings. Work with study sponsors.
Obtain informed consent, particularly as it relates to drug intervention trials. Provide detailed teaching for drug risk and potential side effects. Evaluate subject understanding of risk. Screen potential volunteers using clinical judgment in reviewing inclusion and exclusion criteria. Obtain detailed medical history. Order appropriate diagnostic tests according to protocol. Coordinate scheduling and execution of patient visits.
Perform tests according to research protocol, including phlebotomy, ECG, specimen collection, and functional measures as deemed necessary for each study protocol.
Other duties as assigned
Bachelor’s degree with major course work in an appropriate health, social or technical field required.
3 years experience in human subject research coordination required
or equivalent combination of education and experience required
Experience as Human Subject Research Coordinator I preferred
Word processing and data analysis software required
Professional Research Coordinator certification (SoCRA or ACRP) 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 053 Ortho, Clinical Research
Schedule: 8 AM-4:30 PM; OCC WKNDS