Quality Compliance Coordinator

GI Alliance is seeking an experienced Quality Compliance Coordinator.

Duties of this position include, but are not limited to, the following:

Position purpose

The Quality Compliance Coordinator is a specialized research professional working with and under the direction of the Quality Assurance Director.

Responsibilities/Duties/Functions/Tasks:

• Weekly review of sites essential documents to include but not limited to ICFs, source documents, shipping records, master randomization lists, and trial monitoring reports.
• Build eSOURCE study documents in RealTime Clinical Trial Management System (RT CTMS) and update as necessary in accordance with protocol amendments
• Build study templates in RT CTMS and update as necessary in accordance with protocol amendments
• Weekly internal data QC in RT CTMS
• Ensure accuracy and quality of clinical research data
• Review practices and training of clinical research personnel and report findings to Quality Assurance Manager
• Create monthly reports on site findings and review with Quality Assurance Manager
• Assume a lead role for the preparation, conduct, and responses to regulatory agency
• Maintains SOP documents and reviews/updates, as necessary
• Design, implement and improve company quality review processes and standards
• Facilitates ongoing trainings for quality staff members as well as clinical research coordinators
• Analyze quality data to find areas for growth and improvement
• Help create strategies to improve quality across sites
• Evaluate quality events, deviations, and queries
• Help implement a strategy for the timely development of electronic source
• Other duties as assigned

Qualifications

Experience:

• Clinical research experience a plus.
• High school diploma or equivalent. Some college preferred.
• Minimum of two (two) years of experience in medical office or clinical research experience

Other Requirements: Occasional travel to other sites

Performance Requirements:

• Knowledge of grammar, spelling, and punctuation.
• Knowledge of purchasing, budgeting, and inventory control.
• Skill in taking and transcribing dictation and 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.

GI Alliance is an Equal Opportunity Employer. We are committed to creating an inclusive, welcoming, and equitable work environment. Our company values and celebrates the diversity of our physicians, staff and patients. We firmly believe our service is greatly enriched by our diversity of thought, experience, perspective, culture, and background.

Please Note: All job offers are contingent on the successful completion of pre-employment criminal history check.

NOTE: ALL APPLICATIONS MUST BE COMPLETED IN FULL FOR CONSIDERATION.

No phone calls or agencies, please.

EEO/AA-M/F/disabled/protected veteran