Quality Assurance Specialist (Auditor), Office of Research Quality Assurance - Georgetown Universit
Quality Assurance Specialist (Auditor), Office of Research Quality Assurance - Georgetown University Medical Center
Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center whose missions of research, teaching and patient care are carried out with a strong emphasis on community outreach and the Jesuit principle of cura personalis — care of the whole person. The Office of Research Quality Assurance (ORQA) promotes overall regulatory compliance to ensure the protection of the rights, welfare, and safety of research subjects and others at the University.
The Quality Assurance Specialist (QAS) supports the implementation of human subject research compliance by conducting internal study audits (cause and not for cause) to assess compliance, assisting in quality assurance training, and developing ORQA policies. S/he conducts internal study audits for compliance with institutional and regulatory requirements regarding clinical research; and reviews study related processes to assure adherence with applicable requirements; and verifies that regulatory files maintained for the study are complete and accurate. Reporting to the ORQA Director, the OAS has duties that include but are not limited to:
- Conducts routine and directed audits of clinical investigations to ensure compliance with University, FDA, Office of Human Research Protections (OHRP), Good Clinical Practice (GCP), and state and federal guidelines.
- Monitors source documents, including informed consent documents, and case report forms for adherence to Good Clinical Practice (GCP); and identifies discrepancies, protocol deviations, and missing data or non-compliance in source records or CRFs.
- Reviews study-related processes to assure adherence with applicable requirements, such as approval of study protocol by appropriate regulatory and/or oversight committees, GUMC policies, the approving IRB, and applicable FDA and other regulatory requirements.
- Verifies that the regulatory files are complete and accurate.
- Documents auditing activities in writing, using appropriate report forms, and communicates such findings to the ORQA Director for dissemination to appropriate study team members.
- Maintains in strict confidence, all confidential information regarding research studies and clinical research study team activities and members.
- Provides audit data to ORQA Director for tracking and reporting purposes.
- Ensures compliance with regulations and controls by examining and analyzing records.
- Represents GUMC in vendor audits and assists in assuring compliance with sponsor corrective action requirements.
- Identifies risks and establishes plans to remediate.
- Assists in orienting and training PIs and other project staff.
- Reports any instances of serious noncompliance discovered in an audit to the ORQA Director.
- Assists the ORQA Director with the development of compliance operational policies and procedures.
- Assists the ORQA Director in preparing for government regulatory inspections.
- With guidance and assistance from the ORQA Director, conducts focused compliance training to all members of the research community of GUMC on an annual and as-needed basis.
- Assists the ORQA Director and all study teams in preparing for government regulatory inspections.
Quality Assurance Training
- Provides Quality Assurance training to Principal Investigators (PIs) and administrators.
- Develops and delivers training modules for PIs on best practices and problem resolution.
- Works with Administrators to broadly disseminate resources for investigators.
- Researches websites, journals, and government publications to keep abreast of new regulations related to clinical research.
- Demonstrates support for compliance in the performance of job duties and responsibilities by developing and maintaining knowledge of, and performing job functions in, compliance with, rules, regulations, policies and statues that affect his/her job.
- Maintains knowledge of and performing job functions in compliance with GUMC policies and procedures; and reports compliance concerns in an appropriate and timely fashion.
- Bachelor's degree in Health Sciences, Health Systems, or a related field
- 5 years of clinical research experience
- 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
- Proficiency in use of Microsoft Office and the ability to learn software programs (e.g., IRB, CTMS, and EMR)
- Research monitoring experience
- Certification as a CCRA or CCRP
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