Clinical Trials Project I A

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.

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ESSENTIAL FUNCTIONS

• Under direction of study team leader, requests, tracks receipt of and reviews regulatory documents and Institutional Review Board (IRB) approved documents received from clinical study sites. Requests and tracks updated documents when necessary. Reviews site informed consents and may advise sites on revisions based on the model consent under the direction of the study team lead. Files correspondence pertaining to the review and approval process in site file.
• Maintains a central file and tracking of professional licenses, human subject protection training and good clinical practice training certification for all active site personnel.
• Assists more senior project managers in preparing for meetings by helping to schedule meetings, manage meeting invitations, open calls and webinars, prepare agendas and distribute materials.
• Demonstrates ability to monitor site IRB expirations and request current approvals as necessary. Utilizes internal tracking system to monitor upcoming IRB expirations and contacts sites to obtain renewals.
• Under direction of study team leader, processes requests for information and documentation from functional groups and compiles information in report-ready format.
• Assists with file archiving of clinical study specific files in a centralized archive to ensure secure storage and retrieval for the custody of study documents.
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and less than 1 year of relevant experience required
• Or equivalent combination of education and experience
• Clinical trials experience preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials preferred
• Strong communication skills, interpersonal skills, attention to detail, and organization skills preferred

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 Classes). 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.