Accomplished medical scientist and director with extensive experience in all aspects of research integrity and compliance across leading academic and governmental institutions. An expert in developing and enforcing research policies, handling challenging compliance investigations, and enhancing organizational research integrity standards. Over a decade of leadership experience in overseeing complex research compliance programs and educational initiatives.
Overview
37
37
years of professional experience
Work History
Director, Office of Research Integrity
University of Southern California
05.2019 - Current
Development of the USC Office of Research Integrity Office
Handle incoming allegations of research misconduct and manage all aspects of misconduct inquiries and investigations, including consulting with Provost, VPR, applicable deans
Subject matter expert and consultant regarding matters of research, academic and professional misconduct
Develop and enforce university research integrity policies and guidance: Research and Scholarly Misconduct Policy on Biorepository Management and Oversight Research Data Management Policy (currently in development) Guidance on Authorship and Attribution Consultant on other research related policy development/revisions
Lead developer of USC Research Data Scholarship Program
Chair of university Research Data Council and Research Data Stewardship Working Group
Review of all USC biorepository establishment applications for policy compliance and approval for Vice President of Research
Conflict of Interest in Research Committee member, Health Science and Main Campus: Review of all research related conflict-of-interest disclosures for university Develop management plans as appropriate Follow up with COI management plan non-compliance
Carry out retrospective COI scientific reviews regarding undeclared foreign interests, exported data and dual use data
Specifically, as it relates to data theft and misappropriation
IRB biomedical application advisor for all USC researchers
Lecture and educate on responsible conduct of research, best research practices and research compliance across the University
Conduct for-cause training for labs or individuals with multiple compliance violations
USC representative AAU/APLU Science and Security Working Group
USC representative National Association of Research Integrity Officers
Member of USC Information Risk Committee, the USC Research Council, Keck Medicine Covid Biorepository Ethics Committee, Keck Medicine Repository Ethics Committee
Director, Clinical Research Compliance
Perelman School of Medicine, University of Pennsylvania
06.2017 - 10.2018
Oversight and management of Perelman School of Medicine Clinical Research Compliance Auditing Program 10 professional staff
Yearly routine, comprehensive audits of all Institutional and Faculty held INDs and IDEs, and associated protocols
For-cause clinical trial audits per-request
Federal Agency Inspection pre-auditing and follow-up assistance
Development and implementation of university policies and procedures to ensure clinical research compliance with federal, state and local regulations as well as ICH Good Clinical Practice Guidance
Provide recommendations for clinical research best practice to the Senior Associate Vice Provost for Human Research, the Vice Provost of Research, the Institutional Review Board, the University Office of Research Integrity, and the University Research Compliance Committee
Close coordination with IRB regarding findings of serious and/or continuing HSP non-compliance
Coordinate with UPenn Office of the Vice President of Research in the oversight of PSOM faculty and staff COI management plans
Provide rapid response guidance and support to clinical research teams to ensure regulatory compliance and human subject protections
Point of communication for FDA and DEA as required
Metric compilation and preparation of Annual Clinical Research Compliance and Integrity reports for University Research Compliance Committee and AAHRPP.
Director, Human Research Integrity and Education
Weill Cornell Medicine
02.2016 - 05.2017
Administrative oversight of the Human Research Protection Program (HRPP) 20 administrative staff
5 institutional review boards (IRBs) reviewing approximately 3,000 protocols annually
Institutional data safety monitoring board (DSMB) reviewing approximately 60 studies annually
Conflict of Interest Office and monthly faculty Conflict Advisory Panel
Review and analysis of current institutional HRPP policies based on the Association for the Accreditation of Human Research Protection Programs’ (AAHRPP) Self-Evaluation Instrument to prepare the institution for AAHRPP step 1 application
Update and develop outdated and missing organizational human research protection policies and procedures
Reorganize HRPP organizational structure to eliminate institutional conflict of interests
Develop and implement a comprehensive not-for-cause audit and education program
Perform and direct for-cause audits of non-compliance and create non-compliance reports to the Federal Office of Human Research Protections as required
Organize Research Integrity and Compliance Working Group to facilitate communication between various research compliance divisions (COI, IRB, IACUC, DSMB, Radiation safety, data security, etc)
Weill Cornell Medicine (WCM) Administrative Representative for the Tri-Institutional (WCM, Memorial Sloan Kettering, Rockefeller University) ESCRO committee
Chair of the Clinical and Translational Science Center (CTSC) Trial Innovation Committee
Member of the CTSC Education and Ethics Committee
Develop and implement educational initiatives for faculty, research and administrative staff
Tri-Institutional Responsible Conduct of Research course facilitator.
Senior Scientist Investigator, Acting Deputy Director, Office of Research Integrity, Division of Investigative Oversight
U.S. Department of Health and Human Services
04.2010 - 01.2016
Medical-science expert responsible for the oversight of institutional research misconduct investigations of federally (PHS) funded basic and clinical research within all biomedical disciplines
Communicate and cooperate with other government grantor agencies, including OHRP, FDA, CDC and VA
Interpret, communicate and enforce the PHS code of federal research misconduct regulations, 42 CFR 93 the common rule, 45 CFR 46
Work closely and cooperatively with national and international academic administrators, providing technical support and guidance in handling allegations and investigations of both basic and clinical research misconduct
Perform site visits when necessary for investigational support and data sequestration
Prepare internal scientific reports and present cases to DHHS Office of General Council
Recommend findings and administrative actions to the Assistant Secretary of Health
Work with DHHS Office of General Council to prepare cases to be brought before the federal administrative law judiciary system
Work with DHHS Inspector General in cases with concurrent criminal charges
Lecture nationally on the responsible conduct of research, clinical research misconduct and human subject protections
Initiate and organize national conferences on the harmonization of conflicting federal regulations in coordination with OHRP, members of the Secretary's Advisory Committee on Human Research Protections (SACHRP) and FDA
Bring together national RIOs, IRB chairs, compliance officers and institutional officials to develop white papers and best practice guidelines for handling overlapping non-compliance issues including, but not limited to research misconduct, human subject protection violations, Institutional Animal Care and Use Committee (IACUC) violations and academic dishonesty
Conduct educational training workshops for institutional Research Integrity Officers (RIOs) nationally on forensic image analysis, handling research misconduct investigations and recognizing misconduct in clinical studies
Consultant for international research policy makers regarding best practices for international research integrity regulations.
Intramural Research Fellow
National Institutes of Health
01.2007 - 01.2010
Function, protein trafficking and protein-protein interactions of murine maternal effect genes in early embryogenesis
Molecular cloning, fluorescent protein labelling, micro-array technology, confocal microscopy, transgenic mouse technology, nuclear and embryo transfer.
Independent Professional Photographer, Digital Photograph Technician
IX International Congress of Reproductive Immunology Young Investigator Award, 2004
Society for Male Reproduction and Urology and the American Society of Reproductive Medicine Traveling Scholars Award, 2004
American Society of Andrology Testes Workshop Travel Award, 2003
Gordon Conference on Mammalian Gametogenesis & Embryogenesis Travel Award, 2002
Scholarship Award to Frontiers in Reproduction Course, Marine Biological Institute, Woods Hole, MA, 2003
Brookhaven National Laboratory’s Women in Science Scholarship, 1995
Outstanding Organic Chemistry Student Award, 1994
Outstanding Freshman Scholarship, 1993
Liberal Arts Academic Excellence Award, SUNY Farmingdale, 1993
Postdoctoral Training
Intramural Research Fellow, National Institute of Diabetes, Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, 2007, 2010
Residency, Obstetrics and Gynecology, Albert Einstein College of Medicine, Bronx, NY, 2005, 2007
Select Invited Talks
Scientific Image Beautification: The Truth Isn’t Always Pretty, Communication seminar for fellowship holders working in North America, Boehringer Ingelheim Fonds at Cold Spring Harbor National Laboratories, Lloyd Harbor, NY, 02/27/2017
Therapeutic Misconception and the Clinical Research Investigator: Beyond Protocol Deviations, Achieving Excellence in Clinical Research Scientific, Ethical and Operational Considerations, Annual Symposium, Advocate Health Care, Oak Brook, IL, 09/30/2016
Research Misconduct in Clinical Trials, Perspectives from the Experts, Association of Research Integrity Officers Annual Meeting, Memorial Sloan Kettering Cancer Center, New York, NY, 09/27/2016
Demystifying the Regulators; What you need to know to get your protocol up and running, Weill Cornell Medicine and Houston Methodist, Mentored Clinical Research Training Program, Weill Cornell Medical College, New York, NY, 07/2016
Therapeutic Misconception and the Clinical Research Investigator, 2016 OHRP Research Community Forum, Vanderbilt University, Nashville, TN, 06/21/2016
Beyond Human Subject Protections: The ramifications of therapeutic misconception on research integrity, the dilemma for the physician researcher and the repercussions of purposeful protocol violation and data falsification, NIH Grand Rounds Series; Contemporary Issues in Graduate Medical Education, National Institutes of Health, Bethesda, MD, 08/05/2015
What is Clinical Research Misconduct? The Knowns and the Grey Areas, Annual NIH Extramural Research Integrity Training Symposium, National Institutes of Health, Bethesda, MD, 07/14/2015
Safeguarding Sound Science: ORI Experience and Oversight, NYU Symposium on Scientific Misconduct, New York University Medical Center, New York, NY, 07/13/2015
What is Clinical Research Misconduct? The Knowns and the Grey Areas, ORI and OHRP 2nd IRB/RIO Conference, Georgetown University, Washington, DC, 06/19/2015
Current Forensic Techniques for the Detection of Manipulated Scientific Data, Forensic Workshop for Research Integrity Officers, University of Michigan, Ann Arbor, MI, 05/08/2015
Safeguarding Sound Science, Research Techniques in the Social Sciences, St. John’s University, Queens, NY, 04/17/2015
Tales of Deception and Detection: Mastering the Art of Scientific Forensic Analysis, Georgetown University, Washington, DC, 04/02/2015
Reconciling Regulatory Frameworks: Dealing with research misconduct involving noncompliance in human subject protections, PRIM&R Advancing Ethical Research Conference, Boston, MA, 12/2014
Clinical Research Misconduct: What You Should Know, Clinical Trials Seminar, NIH Clinical Coordinator Seminar, National Institutes of Health, Bethesda, MD, 10/01/2014
The Research Clinic: Uses for IRB Training and Education, Special Training Symposium, NIH Quality Assurance Professional Advisory Committee and IRB Chairs, National Institutes of Health, Bethesda, MD, 05/14/2014
Misconduct in Clinical Research: An ORI Perspective, Invited Speaker National Institute of Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, 01/2014
Alleged Misconduct in Clinical Research: Challenges for IRBs and Research Integrity Officers, PRIM&R Advancing Ethical Research Conference, Boston, MA, 11/09/2013
Clinical Research Misconduct: What You Should Know, Invited Speaker, NIH Quality Assurance Professional Advisory Committee, National Institutes of Health, Bethesda, MD, 11/13/2013
Research Misconduct in the Clinical Setting: ORI Experience and Oversight, Annual NIH Extramural Research Integrity Training, National Institutes of Health, Bethesda, MD, 07/2013
Detection of Manipulated Scientific Data, Invited Speaker, NIH SRO Council, NIH Center for Scientific Review, National Institutes of Health, Bethesda, MD, 01/2013
Clinical Research Misconduct: What We Know, ORI and OHRP Sponsored RIO/IRB Meeting, Georgetown School of Medicine, Washington, DC, 01/2013
Safeguarding Sound Clinical Science: Lessons from the Past, Research Integrity Misconduct Workshop, Quest for Research Excellence Conference, Georgetown University, Washington, DC, 03/2012
Safeguarding Sound Science: Avoiding the pitfalls of research misconduct and mentoring for success in scientific integrity, Dean’s Grand Rounds, State University of New York Upstate Medical College, Syracuse, NY, 09/2011
Safeguarding Sound Science: Avoiding the Pitfalls of Research Misconduct and Mentoring for Success in Scientific Integrity, Frontiers in Reproduction, Marine Biological Laboratory, Woods Hole, MA, 05/2011
The Lab, Frontiers in Reproduction, Marine Biological Laboratory, Woods Hole, MA, 05/2011
Publications
Grace KS, Sinclair KD. 2009. ART, Epigenetics and Long Term Health: A developmental time bomb still ticking. Semin Reprod Med. 27(5):409-16.
Grace KS, Bronson RA, Ghebrehiwet B. 2003. Ligation of the C1q Receptor, gC1qR/p33, Associates with Both the avb3 Integrin and Vitronectin and Causes Protein Phosphorylation. Fertil Steril. 80(sup 3).
Grace KS, Bronson RA, Ghebrehiwet B. 2002. Surface Expression of Complement Receptor gC1q-R/p33 Is Increased on the Plasma Membrane of Human Spermatozoa after Capacitation. Biol Reprod. 66: 823-9.
Additional Professional Training
Wicklander-Zulawski Non-Confrontational Interrogation and Interview Techniques, 2015
Postgraduate Course - Men’s Health: On the Horizons of Andrology, American Society of Andrology, Baltimore, MD, 2004
Gamete Development, Genetics and Testing in Male Reproductive Failure, American Society for Reproductive Medicine Postgrad Program, 2003
XVII Testes Workshop: Functional Genomics of Male Reproduction, American Society of Andrology, 2003
Frontiers in Reproduction, Marine Biological Laboratory, Woods Hole, MA, 2001
Timeline
Director, Office of Research Integrity
University of Southern California
05.2019 - Current
Director, Clinical Research Compliance
Perelman School of Medicine, University of Pennsylvania
06.2017 - 10.2018
Director, Human Research Integrity and Education
Weill Cornell Medicine
02.2016 - 05.2017
Senior Scientist Investigator, Acting Deputy Director, Office of Research Integrity, Division of Investigative Oversight
U.S. Department of Health and Human Services
04.2010 - 01.2016
Intramural Research Fellow
National Institutes of Health
01.2007 - 01.2010
Independent Professional Photographer, Digital Photograph Technician
Research Assistant – AI for Media and Storytelling (AIMS) at University of Southern CaliforniaResearch Assistant – AI for Media and Storytelling (AIMS) at University of Southern California