Clinical Research Auditor

Job Details

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Job ID:
25867

Location:
10 Brookline Place West, Brookline, MA 02445

Category:
Clinical Research

Employment Type:
Full time

Work Location:
Full Remote: 4-5 days remote/wk

Overview

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

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, national protocol and investigator registrations, DF/HCC multi-center coordination oversight, participation in general clinical trials education, and committee management.  Clinical Research Auditor reports to the Data & Safety Monitoring Manager.

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. 

Requirements

  • The Clinical Research Auditor III will perform a minimum of 24 audits of DF/HCC clinical trials annually.
  • Scheduling approximately 2 audits a month with the appropriate research study teams at DFCI, MGH, BWH, BIDMC, BCH, their Affiliates and at external sites engaged in multi-center research.
  • Prepare for scheduled audit by thoroughly reading and understanding selected protocol requirements, federal regulations, Good Clinical Practice guidelines and DF/HCC policies
  • Conduct pharmacy and regulatory reviews for the selected protocol
  • Conduct audit of selected participant’s source documentation including review of the electronic medical record, research files, labs etc.
  • Summarize and present audit findings to the Overall Principle Investigator (PI), Site PIs, and study staff at the end of on-site auditing activities during an exit interview.
  • Train investigators and study staff in documentation of clinical trial activity, protocol compliance and regulatory requirements.
  • 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 appropriate repositories.
  • Provide support for the maintenance of the DF/HCC Clinical Trial Audit Manual, DF/HCC Standard Operating Procedures (SOPs) pertinent to clinical trial auditing and the audit database
  • Coordinate logistics and troubleshoot problems, such as space and access to electronic records, that may be encountered by the clinical research auditors across the DF/HCC institutions
  • Identify needed DF/HCC system changes within DF/HCC through the extrapolation of the audit findings
  • Provide guidance and mentoring to junior staff through co-auditing during initial training of new hires and act as a subject area expert to junior peers. 
  • May perform special audits upon request (mock audits, Office for Humans Research Studies (OHRS) file reviews, IRB, Affiliate site audits, etc.) or may perform special projects at the request of the ODQ Director or Data & Safety Monitoring Manager.

Note: This position requires periodic domestic and possibly international travel. The amount of travel should not exceed an average of 15%.

Qualifications

  • Bachelor’s Degree in a Scientific Field.
  • 3-5 years clinical research auditing or monitoring experience, oncology research preferred
  • Certified Clinical Research Profession (CCRP) from an approved accrediting organization

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

  • Comprehensive 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.
  • Ability to work effectively with departmental peers, investigators and study teams.
  • Must be detail oriented and well organized.

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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