Clinical Trials Project Specialist 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. 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 108 H

Compensation Range:

$24.91 - $34.87 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:

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.

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 required Or equivalent combination of education and experience required 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 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.