Job Board

Dept Number/Name: 0-7910-000 / Research Integrity &Compliance

College Division: Research-IntegrityandCompliance

Salary Plan: Administrative

Job Code/Title: 4766 / QAQI Compliance Auditor SR RCA

Hiring Salary/Salary Range:$61,500 - $70,000

Position Number: 00033312

Schedule: Hybrid (In person for training, then remote) 8:00 AM - 5:00 PM

ORGANIZATIONAL SUMMARY:

Research Integrity & Compliance is a unit within the USF vice presidential area, Research & Innovation. The main function of RIC is to ensure compliance with federal and state regulations pertaining to the responsible conduct of research. The Division is responsible for such programs as the Human Research Protection, Animal Safety, Diving Safety, Radiation Safety, Biosafety, Scientific Misconduct, Conflicts of Interest in Research, Foreign Influence, Export Control and HIPAA, among others. RIC has 35 employees and an annual budget of nearly $3 million. Clients are USF research faculty, students, and staff, as well as researchers at affiliated institutions.

POSITION SUMMARY:

The Quality Assurance/Quality Improvement (QA/QI) Compliance Auditor Research Compliance Administrator (RCA) Senior position conducts random monitoring and for-cause audits of Institutional Review Board (IRB) approved studies for compliance with federal regulations, state law, AAHRPP accreditation standards, and USF policies and procedures related to the protection of human subjects in research. This includes extensive written and oral communication between the QA/QI Program, Human Research Protection Program/IRB, the Principal Investigator, and research teams to assist with IRB oversight and investigator compliance in human participant research.


RESPONSIBILITIES:

Monitors the performance of randomly-selected USF IRB-approved protocols and performs for-cause audits (situations of known or suspected noncompliance with federal regulations, state laws, AAHRPP-accreditation standards, and/or HRPP/IRB policies and procedures) of human participant research.

Serves as a liaison between the human subject researchers and the Institutional Review Board (e.g., assisting investigators with corrective and preventative action plan development, presenting monitoring activities results to the IRB, etc.).

Performs quality improvement assessments of the HRPP as directed by the QA/QI Program Manager, including but not limited to review of the IRB files.

Perform QA/QI educational outreach initiatives (e.g. best practices training regarding regulatory records maintenance, helping researchers prepare for external site visits (sponsor monitoring visits, FDA audits, etc.)).

Provides data management support for the QA/QI documentation (e.g., maintain QI files; keeps QA/QI tracking files updated; oversees and  keeps QA/QI file log up-to-date). Assists the QA/QI Program Manager with special projects, e.g., the Adverse Event database, as needed

Performs other duties as assigned to support department and unit needs.

POSITION QUALIFICATIONS:

MINIMUM:

This position requires a Bachelor's degree, five to six years of experience in Human Subject research, and applicable certification (i.e. Certified Professional in IACUC Administration (CPIA)/Certified IRB Professional (CIP)/other applicable) or a Master's degree with three years of experience in Human Subject research or research administration and applicable certification (i.e. Certified Professional in IACUC Administration (CPIA)/Certified IRB Professional (CIP)/other applicable).

PREFERRED:

Master's degree in nursing, health administration, or similar field relating to health care research and/or human subjects research administration/management a plus. Experience monitoring or auditing human subjects research. Research experience conducting FDA regulated studies and following Good Clinical Practice (GCP) guidelines. Possesses basic medical knowledge and understands medical terminology. Data management software as well as USF Business Enterprise applications (GEMS, OASIS, InfoEd, Click Commerce) experience desired. Skilled with professional writing and electronic correspondence in Microsoft based software.
 

Information for Applicants 

This position is subject to a Level 1 criminal background check.

Job Opening Number: #33099

Posting Date:  1/12/2023

How To Apply 

Click on the Apply Now button.  When applying to an opening you will have the opportunity to upload a cover letter and resume.

Apply online by completing the required information and attaching your cover letter and resume. Please include your experience as it relates to the qualifications stated above.  YOUR COVER LETTER AND RESUME, PLUS ANY OTHER REQUESTED MATERIAL, MUST BE IN ONE ATTACHMENT. Only online applications are accepted for this position.

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Equal Employment Opportunity 

USF is an equal opportunity, equal access academic institution that embraces diversity in the workplace.

The University of South Florida does not discriminate on the basis of sex and prohibits sexual harassment. Any person may report sex discrimination, including sexual harassment (whether or not the person reporting is the person alleged to be the victim of conduct that could constitute sex discrimination or sexual harassment), in person, by mail, by telephone, or by electronic mail, using the contact information listed for the Title IX Coordinator. Reports may be made at any time either online or directly to the University's Title IX Coordinator.

Work Location 

Campus map and location overview: USF - Tampa Campus

About USF 

The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News and World Report's national university rankings than USF. Serving more than 50,000 students on campuses in Tampa, St. Petersburg and Sarasota-Manatee, USF is designated as a Preeminent State Research University by the Florida Board of Governors, placing it in the most elite category among the state's 12 public universities. USF is a member of the American Athletic Conference.

Working at USF 

With more than 16,000 employees at USF, the University of South Florida is one of the largest employers in the Tampa Bay region.  At USF you will find opportunities to excel in a rich academic environment that fosters the development and advancement of our employees.  We believe in creating a talented, engaged and driven workforce through on-going development and career opportunities. We also offer a first class benefit package that includes medical, dental and life insurance plans, retirement plan options, tuition program and generous leave programs and more.