Lead Research QA Specialist

Location: City of Rochester

Lead Research QA Specialist page is loaded## Lead Research QA Specialist remote type:
Hybrid locations:
Saunders Research Building time type:
Time as Reported / Per Diem posted on:
Posted Todayjob requisition :
R269461

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:

Time as Reported / Per Diem Scheduled Weekly

Hours:

As Scheduled Department:400981 Neuro-Ctr Health & Tech/CTCC

Work Shift:

UR - Day (United States of America)
Range:

UR URG 114 HCompensation Range:$41.58 - $62.37
* 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:
** Establishes, manages, and provides oversight of Quality Assurance functions within the CHeT QA team. Partners with internal and external stakeholders to lead and manage quality initiatives to meet business requirements in accordance with University policies, the department's standard operating procedures, and federal and local regulations to promote the highest quality of studies.
** ESSENTIAL FUNCTIONS
*** Facilitates and manages the Quality Management Systems (QMS) program. Leads and hosts compliance audits and regulatory inspections by competent regulatory authorities and external clients, and Internal International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Audits). Supports implementation of continuous improvement of the QMS. Develops, designs, and implements strategic audit plans based on regulatory standards, risk assessment, Department and client needs, as well as study functions.

Develops internal standard operating procedures (SOPs) which guide all areas of the Quality Management System. Manages all related documentation within a document management system/(e)
QMS.
* Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams and processes. Provides expertise and guidance in interpreting regulations, agency guidelines and internal procedures to ensure continued compliance and process improvement. Develops relationships within the University as well as with counterparts in client organizations. Interfaces with management to discuss quality and compliance issues.
* Serves as the ambassador for the department by liaising with external study sponsors, internal departments and study teams to make recommended revisions to processes and procedures. Provides actionable insights from quality and operational data analysis and proactively works with the sponsor and internal teams to develop action plans to drive continuous improvement. Advises customer quality counterparts on the strategy for regulatory inspections.

Collaborates in the preparation and management of internal and external inspections. Oversees the quality management of computer systems used in Clinical Trials to ensure compliance with governmental regulatory requirements.
* Provides expertise, training, and advice on clinical trial industry best practices, governmental regulations, ICH Guidelines, and other relevant quality compliance requirements of major regulatory agencies to Principal Investigators, study teams, study sponsors, and internal and external partners. Provides internal teams direction for continuous improvement. Responsible for mentoring internal staff not limited to Clinical Project Managers and Monitors with risk-based monitoring and risk-based plans.

Presents educational programs and provides guidance…