Clinical Trials Project Specialist I A

University of Rochester•City of Rochester, NY

1d•$25 - $35•Onsite

About The Position

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. This role assists with coordinating all aspects of multi-center international clinical research trials in a Contract Research Organization (CRO) environment. Supports the clinical study team by assisting with collection and tracking of study related regulatory documents from study sites and maintaining study files. Assists senior peers in supporting clinical trial sites. Helps to prepare for various clinical study meetings involving both internal and external teams.

Requirements

Bachelor's degree required
Equivalent combination of education and experience required

Nice To Haves

Clinical trials experience preferred
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

Responsibilities

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.