Clinical Research Auditor I
- Location: Boston, MA
- Posted: Sep 20, 2019
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; 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/HCCs 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 will audit clinical research protocols as assigned by The Data & Safety Monitoring Manager.
Prepare for scheduled audit by thoroughly reading and understanding assigned 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 participants source documentation including review of the electronic medical record, research files, labs etc.
Under supervision, 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.
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 as instructed.
Note: On-boarding typically requires 6-8 months of on the job training where the new hire will co-audit with a senior staff member.
1 year of relevant clinical research experience, oncology research preferred
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.
- full time