Quality Assurance Auditor, Research Compliance Specialist - Lombardi Comprehensive Cancer Center

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Requirements

Georgetown University’s Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center, seeks to prevent, treat and cure cancers by linking scientific discovery, expert and compassionate patient care, quality education and partnership with the community — guided by the principle of cura personalis, “care for the whole person.” Georgetown Lombardi is the research engine driving clinical cancer research at MedStar Health in the D.C. Metro area and Hackensack Meridian Health in northern New Jersey.

The Quality Assurance Auditor, Research Compliance Specialist works in the Office of Research Quality Assurance (ORQA), an office within the office of Human Subjects Protections (OHSP), will support the Senior Director of the OHSP by conducting internal routine audits of clinical investigations at Lombardi Comprehensive Cancer Center (LCCC) to ensure compliance with University, FDA, Office of Human Research Protections (OHRP), Good Clinical Practice (GCP), state and federal guidelines. These audits will also support the compliance with the Data and Safety Monitoring Plan (DSMP) and the outcomes will be reported to the Data and Safety Monitoring Committee (DSMC) at quarterly meetings. The incumbent will also interact with outside study sponsors, monitors and auditors, including federal agencies. Reporting directly to the senior auditor in ORQA who will work with the RCS-I to set audit priorities and timelines, additional duties include, but are not limited to:

• Conduct routine full scope audits of investigator-initiated trials at LCCC.

• Review source documents including but not limited to informed consent forms and case report forms for adherence to protocol and GCP.

• Review regulatory documents and IRB submissions for adherence to appropriate regulatory and/or oversight committees, GUMC policies, the approving IRB, and applicable FDA and other regulatory requirements.

• Document auditing activities in writing, using appropriate report forms and communicate such findings to the Senior Director of OHSP in appropriate timelines for dissemination to appropriate study team members, department leadership as well as the DSMC.

• Represent GUMC in external audits and assist in assuring compliance with sponsor corrective action requirements.

• Work collaboratively with other GU regulatory departments, such as the IRB or the Office of Research Oversight (ORO), when needed to ensure understanding of all regulatory aspects of the study.  

• Effectively interact within the OHSP team to ensure compliance oversight priorities of the organization are met. 

Requirements and Qualifications

• Bachelor’s degree in Health Sciences, Health Systems, or a related field

• Two years of Clinical Research Quality Assurance or similar clinical research experience or educational equivalent

• Strong understanding of FDA, ICH and other regulatory and audit issues in clinical trials and compliance.  An understanding of medical terminology and technical writing

• Excellent interpersonal communication, including verbal and written

• Proficient in Microsoft Office and possess the ability to learn software programs (e.g., IRB, CTMS, EMR)

• Experience with oncology trials is a plus

• Research monitoring or auditing experience and/or certification as a CCRA or CCRP is preferred but not required

Work Mode Designation

This position has been designated as Hybrid. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University.  Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation.

Pay Range:

The projected salary or hourly pay range for this position wh