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Quality Assurance Auditor
Company: University of Miami Health System
Location: Miami, FL
Employment Type: Full Time
Date Posted: 09/25/2021
Expire Date: 11/25/2021
Job Categories: Education
Job Description
Quality Assurance Auditor
Description:

The Office of the Vice Provost for Research & Scholarship, Research Compliance & Quality Assurance Office (RCQA) has an exciting job opportunity for an Auditor position.

CORE JOB SUMMARY

Th

e Quality Assurance Auditor conducts routine and focused audits of human subject research protocols to ensure compliance with federal and local regulations and guidelines and research site specific Standard Operating Procedures (SOPs). The Quality Assurance Auditor reports to the RCQA (Research Compliance and Quality Assurance) Executive Director.

Core Job Functions

Conducts reviews of protocol and other submissions and communicates with researchers as it relates to regulatory deficiencies and University policies.

Provides QA or QC functions.

Assists with Project Management.

Creates and adheres to metrics-driven timelines.

Creates and presents research-related educational materials within and outside the University of Miami

Prepares documents for submission to federal agencies.

Keeps abreast of current federal regulations and guidance documents, State laws, University of Mi
am
i policies and procedures as well as departmental SOPs and informs OVPRS leadership of changes.

Promotes quality improvement and best practice solutions.

Communicates with the research community, all OVPRS groups and external customers as applicable and provides consistent excellent customer service.

DEPARTMENT SPECIFIC JOB FUNCTIONS

Conducts routine and focused audits of human subject research protocols to ensure compliance with federal and local regulations and guidelines and research site specific SOPs.

Conducts routine and focused audits of the Institutional Review Board/Human Subjects Research.

Office to ensure compliance with applicable regulations, guidelines, and internal SOPs related to their review, approval and oversight of human subject research studies.

Provides guidance and support in the development of Corrective and Preventive Action Plans.

Conducts imp
leme
ntation reviews and effectiveness checks of CAPA Plans.

Advises RCQA leadership of deficiencies and recommends necessary corrective and preventive actions.

Prepares reports for RCQA and UM leadership as needed.

Assists in the preparation and presentation of research compliance related educational programs to groups and individuals in the University research community.

Monitors new legislation or changes in regulations that might affect the Universityís compliance in conducting research, recommending changes to administrative policies and procedures, as appropriate.

Interacts with appropriate persons and agencies (e.g., Human Subjects Research Office, Privacy Office, Billing Compliance, etc.) to resolve research-related compliance problems.

Assists RCQA leadership in the creation and maintenance of internal policies and SOPs as well as University-wide policies intended to assist University researchers in maintainin
g comp
liance with research standards and guidelines.

Works on projects assigned by the Executive Director.

Assists RCQA leadership in the creation and maintenance of RCQA-related databases and electronic audit files.

Adheres to University and unit-level policies and procedures and safeguards University assets.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

CORE QUALIFICATIONS

Education:

Bachelorís Degree in Science, Health Care, or related field. Masterís Degree preferred.

Certification and Licensing:

Professional certification in at least one of the following areas: clinical research, research compliance, auditing, GCP related field is highly preferred.

Expe
rience:<
/strong>

Minimum 2 years of relevant experience of effective work-related research experience, including research compliance or study coordination, auditing, or monitoring experience. Working knowledge of federal regulations related to clinical research and Good Clinical Practice (GCP) is required. Any appropriate combinatio
n of relevant education and/or work experience may be considered.

Knowledge, Skills and Attitudes:

Ability to communicate effectively in (English) both oral and written form.

Ability to maintain effective interpersonal relationships.

Ability to deal professionally with all types of information including that of a confidential nature is required.

Excellent organizational skills with strong attention to detail/accuracy and set priorities and effectively perform a variety of tasks simultaneously.

Proficiency using Microsoft Office products (Microsoft Wor
d, Excel,
PowerPoint, and SharePoint) with excellent data management skills.

Ability to learn, lead, motivate, develop and train others.

Ability to recognize, analyze, and solve a variety of problems.

Ability to exercise sound judgment in making critical decisions.

Must be able and willing to provide excellent customer service at all times.

Ability and willingness to provide continuous quality improvement.

Contact Information
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