As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. **Job Location (Full Address):** 601 Elmwood Ave, Rochester, New York, United States of America, 14642 **Opening:** Worker Subtype: Regular Time Type: Full time Scheduled Weekly Hours: 40 Department: 400133 Ophthalmology M&D Work Shift: UR - Day (United States of America) Range: UR URG 110 H Compensation Range: $29.05 - $40.67 _The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._ **Responsibilities:** GENERAL PURPOSE: Under general direction and latitude for independent judgment, serves as study lead at the senior professional level. Manages communication and shared activities for human subject research studies involving units within and external to the University. **ESSENTIAL FUNCTIONS** **Regulatory/Study Administration Responsibilities:** + Responsible for all aspects of clinical trial start-up oversight including protocol review, regulatory document preparation, and consent form preparation, and submission to IRB. + Ensures maintenance of all human based study's regulatory records and subject study files. Oversees and participates in internal research audits and provides audit support in the case of internal audit, sponsor audit or FDA audit. **Sponsor Interaction:** + Point person for any human based research start up. Serve as liaison between sponsor and the study team for regulatory documentation, IRB submissions, and initial budget and contract discussions. May provided input on study budgets. **Training Responsibilities:** + Provides training and mentors research coordinators of various levels for their study activities as well as work with current and future coordinators to train and educate them across all aspects of clinical research activities. May as part of the hiring group for future research staff, primarily coordinators. Educates departmental staff on studies to ensure proper scheduling, billing and screening of subjects. Works with study teams to educate on institutional SOPs for conducting research. Re-educates as needed. May work directly with student, resident and fellow assisted research projects to ensure that proper training is in place and departmental guidelines are being followed. **Financial Responsibilities:** + Establishes study-specific processes for payment of subject stipends. As applicable, ensures proper allocation of expenses, equipment and study materials. Regular reporting to Clinical Research Regulator Manager to track financial wellbeing of studies as well as enrollment goals. + Assess potential new human subject research through internet searches, sponsor contacts, and networking. Completes feasibility questionnaires as needed. Attend educational courses and seminars as appropriate to increase job knowledge. Keep up to date with current regulations for conducting clinical studies according to good clinical practices. + Keeps current with all federal, state, sponsor and institutional policies and laws, SOPs and guidelines. Manages and evaluates resulting study changes. Demonstrates accountability for continuous learning in accordance with GCPs. Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies for the purpose of implementing, managing and evaluating resulting study changes. Other duties as requested. **QUALIFICATIONS** + Bachelor’s degree and 5 years of experience in human subject research coordination; or an equivalent combination of education and related experience. + Knowledge of word processing and data analysis software. + Professional Research Coordinator Certification (i.e., SoCRA or ACRP) preferred. + Experience as Human Subject Research Coordinator II preferred. **EOE Minorities / Females / Protected Veterans / Disabled:** 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. Notice: If you are a **Current** **Employee,** please **log into myURHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward. **Learn. Discover. Heal. Create.** Located in western New York, Rochester is our namesake and our home. One of the world’s leading research universities, Rochester has a long tradition of breaking boundaries—always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better. If you’re looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals At the University of Rochester, we commit to diversity, equity, and inclusion and united by a strong commitment to be ever better—Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.