Quality Assurance Manager (30784) at GI Alliance – Austin, Texas

Quality Assurance Manager (30784)
Job DetailsJob Location: Urology Austin Atrium - Austin, TX 78759
Position Type: Full Time
Job Shift: Any
Description

Quality Assurance Manager

Company Conformance Statements
In the performance of their respective tasks and duties all employees are expected to conform to the following:

Perform quality work within deadlines with or without direct supervision.

Interact professionally with other employees, customers and suppliers.

Work effectively as a team contributor on all assignments.

Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations.

Position purpose
The Quality Assurance Manager ensures the compliance of research study conduction and the integrity of the data across all research sites nationwide.
Responsibilities/Duties/Functions/Tasks:

Manage and oversee quality assurance teams

Design, implement and improve company quality review processes and standards

Facilitates ongoing trainings for quality staff members

Analyze quality data to find areas for growth and improvement and report quality data metrics to leadership

Determine yearly internal audit scheduling alongside VP of Research

Create reports to track quality progress across sites and studies

Create strategies to improve quality across sites

Evaluate quality events, deviations, and queries

Oversees and tracks the timely development of source in collaboration with local site teams

Ensures all source updates are completed in a timely manner

Quality checks source prior to releasing to the operations team

Ensures source documents are reviewed across all sites and studies on a regular and rotating basis

Communicate any critical compliance risks noted from quality checks to senior management.

Assume a lead role for the preparation, conduct, and responses to regulatory agency, sponsor or IRB audits

Maintains SOPs and coordinates yearly reviews and updates as needed

Works alongside local site leadership to ensure completion of all audit findings

Owns CAPA process and supports CAPA initiation and completion

Other duties as assigned

Qualifications

Qualifications

Qualifications
Education:

Bachelor’s Degree from an accredited university preferred

Clinical Research Certification preferred

Experience:

Minimum of 3 years of Supervisory/Management experience required

Minimum of 4 years of clinical research required

Research audit/monitor experience preferred

Other Requirements: Travel within the United States required

Performance Requirements:

Knowledge of grammar, spelling, and punctuation.

Skill in operating office equipment.

Skill in answering the phone and responding to questions.

Skill in time management, prioritization, and multitasking.

Skill in writing and communicating effectively.

Ability to work under pressure, communicate and present information.

Ability to read, interpret, and apply clinic policies and procedures.

Ability to identify problems, recommend solutions, organize and analyze information.

Ability to multi-task, establish priorities, and coordinate work activities.

Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software.

Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.

Work Environment: Position is in a well-lighted medical office environment. Occasional evening and weekend work. Up to 50% in and out of state travel is required.

Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90 percent of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines.
Employee acknowledgement/date
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