Summary
Overview
Work History
Education
Skills
Scholarships And Awards
Postdoctoral Training
Select Invited Talks
Publications
Additional Professional Training
Timeline
Generic

Kristen Grace

Marina del Rey,CA

Summary

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

01.1987 - 01.1997

Education

MD, Medical Scientist Training Program -

State University of New York at Stony Brook
01.2005

PhD, Molecular & Cellular Developmental Biology - Male Gamete Molecular Biology

State University of New York at Stony Brook
01.2003

BS, Biochemistry -

State University of New York at Stony Brook
01.1997

AS, Interdisciplinary Studies -

State University of New York at Farmingdale
01.1994

Skills

  • Creativity and Innovation
  • Expert Regulatory Knowledge
  • Policy Development and Implementation
  • Leadership and Team Management

Scholarships And Awards

  • 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

01.1987 - 01.1997

MD, Medical Scientist Training Program -

State University of New York at Stony Brook

PhD, Molecular & Cellular Developmental Biology - Male Gamete Molecular Biology

State University of New York at Stony Brook

BS, Biochemistry -

State University of New York at Stony Brook

AS, Interdisciplinary Studies -

State University of New York at Farmingdale
Kristen Grace