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):** 265 Crittenden Blvd, Rochester, New York, United States of America, 14642 **Opening:** Worker Subtype: Regular Time Type: Full time Scheduled Weekly Hours: 40 Department: 400981 Neuro-Ctr Health & Tech/CTCC Work Shift: UR - Day (United States of America) Range: UR URG 109 H Compensation Range: $26.90 - $37.66 _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:** Supports all aspects of clinical research trials. Supports the clinical study team by assisting with collection, tracking, and review of study related regulatory documents from study sites and maintaining study files. Assists senior peers in supporting clinical trial sites. Helps prepare for various clinical study meetings involving both internal and external teams. **ESSENTIAL FUNCTIONS** + Requests, tracks receipt of, and reviews regulatory documents. Requests and tracks updated documents when necessary. Collaborates with study team to ensure that study file content and format are consistent with Good Clinical Practice, applicable regulations, and Standard Operating Procedures. + Reviews site revisions to informed consent, ensures site changes are acceptable and advises sites when study documents are ready for Institutional Review Board (IRB) submission. Assists sites with questions related to IRB submissions as needed, under direction of senior peers. + Under direction of senior peers, develops draft informed consent documents. Drafts revisions to existing informed consent documents to reflect changes in study protocol when necessary. + Assists senior peers in preparing for meetings. Drafts minutes for project team meetings under the close supervision, direction and review of study team lead. + Demonstrates ability to prepare IRB submissions. + Oversees and coordinates human subject research activities for single and multiple sites. Develops, implements, and evaluates recruitment strategies, information, data systems, and study management systems. Participates in the planning, development, and implementation of a study design, budgets, protocols, consent forms, processes, and policies, including multiple therapeutic areas. Participates in the development, review, and approval of case report forms and study specific procedure manuals and documents. + Other duties as assigned. **MINIMUM EDUCATION & EXPERIENCE (Required)** + Bachelor's degree + 1 year or relevant experience + Or equivalent combination of education and experience **KNOWLEDGE, SKILLS AND ABILITIES (Preferred)** + Clinical trials experience + Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials + Strong communication skills, interpersonal skills, attention to detail, and organization skills The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture 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 characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law. 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 are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are 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.