Research Quality Assurance Auditor

## Research Quality Assurance Auditor Apply remote type:
Hybrid locations:
Coral Gables, FLtime type:
Full time posted on:
Posted Yesterday job requisition :
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The Research Quality Assurance (RQA) team within the Office of the Vice Provost for Research & Scholarship (OVPRS) has an exciting job opportunity for a Research Quality Assurance Auditor to work at the University of Miami.
** CORE JOB SUMMARY
** The Research 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 Research Quality Assurance Auditor reports to the Director, Research Quality Assurance.

** CORE JOB FUNCTIONS
*** Conducts routine and focused audits of human subject research protocols to ensure compliance with FDA GCP and other federal regulations, ICH-GCP guidelines, and internal policies and procedures.
* Conducts audits of IND/IDE multi-center studies, including external sites.
* Prepares audit reports and reports of investigations/inquiries.
* Assists study teams in creating corrective and preventive action (CAPA) plans in response to internal audits.
* Conducts CAPA implementation follow up reviews to ensure all actions have been completed.
* Advises RQA leadership of deficiencies and recommends necessary corrective and preventive actions.
* As requested by RQA leadership, investigates and/or conducts inquiries of laboratories and research protocols.
* Assists in the preparation and presentation of educational classes to the University research community.
* Monitors new legislation or changes in regulations that might affect the University’s compliance in conducting research, recommending changes to administrative policies and procedures, as appropriate.
* Collaborates with internal units (e.g., Human Subjects Research Office, Privacy Office, University Compliance, etc.) to resolve research-related compliance issues.
* Assists RQA leadership in the creation and maintenance of internal policies and SOPs as well as University-wide policies.
* Maintains RQA related databases, electronic audit files and metrics.
* 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:

Bachelor’s Degree in Science, Health Care, or related field. Master’s Degree preferred. Nursing degree desirable.

Certification and Licensing:

Professional certification in at least one of the following areas: clinical research, research compliance, auditing. One of the following certifications is desirable: RQAP-GCP, CHRC, CCRC, CCRP

Experience:

Minimum 1 year (preferably 2 years) of work-related research experience, including research compliance or study coordination, auditing, or monitoring experience. Working knowledge of FDA, OHRP and ICH-GCP regulations and guidelines, in regards to clinical research and Good Clinical Practice (GCP) is required. Any appropriate combination 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.
*…