GENERAL PURPOSE:

　　The responsibility of the Clinical Project Coordinator I is to help coordinate all aspects of multi-center international clinical research trials in a Contract Research Organization (CRO) environment. The Clinical Project Coordinator I supports the clinical study team by assisting with collection and tracking of study related regulatory documents from study sites and maintaining study files. Individuals assist more senior Clinical Project Coordinators in supporting clinical trial sites. Responsible for helping prepare for various clinical study meetings involving both internal and external teams.

　　JOB DUTIES AND RESPONSIBILITIES:

　　Under direction of study team leader, requests, tracks receipt of and reviews regulatory documents and 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 (e.g., Data Management and Biostatistics) 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

　　QUALIFICATIONS:

　　Bachelor’s degree with major course works in appropriate health, social science, or biological science field (or equivalent combination of education and experience) required

　　Some clinical trials experience preferred

　　Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials preferred.

　　Strong verbal and written communication skills, interpersonal skills, attention to detail and organization preferred

　　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.

　　How To Apply

　　All applicants must apply online.

　　EOE Minorities/Females/Protected Veterans/Disabled

　　Pay Range

　　Pay Range: $23.80 - $33.32 Hourly

　　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.

　　Location: School of Medicine & Dentistry

　　Full/Part Time: Full-Time

　　Opening: Full Time 40 hours Grade 051 CCRC

　　Schedule: 8 AM-4:30 PM