Clinical Research Auditor I

Overview

The work location for this position is full remote, however the selected candidate must live and work from one of the New England states (ME, NH, VT, MA, RI, CT)

The Office of Data Quality (ODQ) provides research support to the Dana-Farber/Harvard Cancer Center with a focus on quality assurance, quality control, and process improvement. Functions of ODQ include protocol subject registration and randomization, clinical research auditing, data and safety monitoring, quality control of DF/HCC initiated clinical trial data, participation in general clinical trials education, and committee management.  The Clinical Research Auditor Ireports to the Associate Director, Data and Safety Monitoring (ADDSM) Clinical Research Auditor

The ODQ Internal Auditing Program is an integral part of the DF/HCC’s clinical research compliance oversight and quality assurance activities. The auditing of clinical trials at the DF/HCC helps to ensure research participant safety, acquisition of high-quality data, and compliance with Federal and State Regulations and Institutional policies and procedures. 

The Clinical Research Auditor I requires comprehension of research study design, federal regulations, and good clinical practices. The Clinical Research Auditor I uses significant judgment and decision making in applying this knowledge to evaluate the conduct of specific research projects.

Responsibilities

• Perform comprehensive audits of clinical research protocols as assigned by the ADDSM.
• This typically includes a minimum of 24 audits of DF/HCC clinical trials annually with approximately 2 audits a month.
• Prepare for scheduled audit by thoroughly reading and understanding assigned protocol requirements, federal regulations, Good Clinical Practice guidelines and DF/HCC policies.
• Conduct regulatory document review for the selected protocol.
• Conduct audit of selected participant’s source documentation including review of the electronic medical record, research files, labs etc.
• Coordinate logistics and troubleshoot problems, such as space and access to electronic records, that may be encountered.
• Summarize and present audit findings to the Overall Principal Investigator (PI), Site PIs, and study staff at the end of on-site auditing activities during an exit interview.
• Analyze audit findings to appropriately assign major or minor violations, rating the audit, and drafting a Final Audit Report for review and approval by the Data & Safety Monitoring Manager.
• Present audit findings to the DF/HCC Audit Committee for final evaluation.
• Document audit findings and outcomes in a formal audit report; maintain data on auditing activities in the OnCore CTMS.
• Participate in other audit activities (mock audits, audits of IRB materials, process improvement audits, external site audits, etc.) as requested by the ADDSM.

Qualifications

• Bachelor’s degree in a scientific field preferred or equivalent work experience. 
• 1 year of relevant clinical research experience, oncology research preferred.  Basic computer literacy and familiarity with Microsoft Office Suite; MS Word, MS Excel required.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Basic understanding of relevant Federal and State regulations and guidelines on clinical research involving human subjects.
• Ability to effectively communicate verbally and through written communication.
• Ability to project a professional demeanor in representing the department to the broader research community.
• Ability to work independently with minimal supervision.
• Must be detail oriented and well organized.

Note: Routine audit activities occur on campus at a location in the greater Boston area when unable to be performed remotely. This is not considered travel since this position is Boston-based. However, auditors may be required to travel periodically for onsite audits of external research sites.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.  As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff.  Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

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