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):
220 Hutchison Rd, Rochester, New York, United States of America, 14620Opening:
Worker Subtype:
RegularTime Type:
Full timeScheduled Weekly Hours:
40Department:
400981 Neuro-Ctr Health & Tech/CTCCWork Shift:
Range:
UR URG 109 HCompensation Range:
$26.90 - $37.66The 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:
GENERAL PURPOSE:
Conducts internal audits of Human Subject Research studies to measure compliance with IRB requirements, the approved protocol, applicable federal regulations, University policies, and best practice (Good Clinical Practice) standards. Conducts internal consultations regarding newly-approved studies with Principal Investigators and study team members to plan for compliance. Strives to improve the quality of research compliance and provides education and feedback to research teams to protect human subjects.Schedule
8 AM-5 PM; OCC WKNDS
Responsibilities
GENERAL PURPOSE:
Conducts audits of Human Subject Research studies to measure compliance with IRB requirements, the approved protocol, applicable federal regulations, University policies, CHeT/CTCC SOPs, and best practice (Good Clinical Practice) standards for multi-site clinical trials conducted by the CTCC. Conducts internal consultations regarding newly-approved studies with Principal Investigators and study team members to plan for compliance. Strives to improve the quality of research compliance and provides education and feedback to research teams to protect human subjects.
RESPONSIBILITIES:
Conducts quality improvement audits for multi-site clinical trials to ensure the protection of human subjects and research is conducted in accordance with Institutional Review Board (IRB) requirements, approved protocol, applicable federal regulations, University policies, CHeT/CTCC SOPs and best practice (Good Clinical Practice) standards, both virtually and in-person. Assists research sites in the preparation for regulatory audits/inspections from governmental agencies, non-profit organizations and research sponsors.
Prepares formal audit reports of findings and provides consultation and educational services to study team(s) at research sites to ensure compliance, improve the research process and support the implementation of corrective and preventative action plans. Assists in the preparation of written summaries of quality improvement
consultation discussions providing resources specific to the approved study.
Provides training and consolation to sites and staff to ensure the protection of human subjects and research is conducted in accordance with IRB requirements, approved protocol, applicable federal regulations, University policies, CHeT/CTCC SOPs and best practice (GCP) standards.
Participates in the communication of activities and results through various means, such as presentations, reports, and newsletters. Maintains current knowledge of Good Clinical Practice (GCP), federal and state regulations, IRB policies and procedures, ethical standards, contemporary trends, and best practices associated with conducting human subject research.
Other duties as assigned.
QUALIFICATIONS:
Bachelor+s degree required
3 years of relevant experience or equivalent combination of education and experience required
Knowledge of ICH, GCP Guidelines, local regulatory authority regulations, competence in electronic data capture systems, risk-based monitoring approach, strong verbal, written communication skills, attention to detail and organizational skills required
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.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.