Clinical Trials Proj Spec I A

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Job Location (Full Address):

601 Elmwood Ave, 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:

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 required

• 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 communication skills, interpersonal skills, attention to detail and organization preferred.

EOE Minorities / Females / Protected Veterans / Disabled:

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.

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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 commit to diversity, equity, and inclusion and 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.