Summary
Overview
Work History
Education
Skills
Selected Continuous Education Activities
Academic Membership
Timeline
Generic

John A. Morais

Silver Spring,MD

Summary

Certified IRB Professional (CIP). Current active Federal Security Clearance: - Secret level. Eighteen years experience in institutional ethics review, human subjects research protections implementation, development of policies and procedures for academic, biomedical, socio-behavioral, and engineering research. Federal Wide Assurance and DoD Assurance regulatory oversight and compliance monitoring. Implementation and oversight of Quality Assurance/Quality Improvement initiatives. In-depth knowledge of the Code of Federal Regulations related to the protection of Human Subjects in Research, “The Common Rule” and subparts B,C,D. Working knowledge of Department of Defense (DoD) Human Subject Protection Instructions: DoDI 3216.02. Extensive experience assessing Human Research Protection Program Offices. Trained on IRBNet, IRBManager, EIRB, Electronic Grants System, Cayuse, and other government and commercial off the shelf electronic IRB and regulatory management systems.

Overview

25
25
years of professional experience

Work History

Research Ethics and Compliance Officer

US Department of Defense
02.2022 - Current
  • Provide real-time oversight of USAMRDC-conducted, supported, and assisted research protocols through timely documented reviews of protocol lifecycle actions to assure ongoing compliance with all applicable Federal, DoD, Dept
  • Of the Army, state, host nation, and USAMRDC human subjects protection regulatory requirements
  • Provide regulatory-based written review of protocol life cycle actions using standardized checklists
  • Delineate deficiencies and areas of noncompliance and make recommendations to the HRPO Federal Approval Authorities (AAs) regarding regulatory and ethical issues in HRPO post-approval submissions
  • Support the HRPO leadership in the conduct of noncompliance investigations and compliance inspections of extramural protocols
  • Assist in development and implementation of internal HRPO operating procedures and work instructions
  • Participate in performance improvement activities and working groups to improve and streamline the protocol review and approvals processes

Human Subjects Protection Scientist III/Team Lead

General Dynamics Health Solutions
10.2019 - 02.2022
  • Company Overview: Contract support for the Office of Research Protections, Human Research Protection Office US Army Medical Research & Development Command (USAMRDC)
  • Provide real-time oversight of USAMRDC-conducted, supported, and assisted research protocols through timely documented reviews of protocol lifecycle actions to assure ongoing compliance with all applicable Federal, DoD, Dept
  • Of the Army, state, host nation, and USAMRDC human subjects protection regulatory requirements
  • Provide regulatory-based written review of protocol life cycle actions using standardized checklists
  • Delineate deficiencies and areas of noncompliance and make recommendations to the HRPO Federal Approval Authorities (AAs) regarding regulatory and ethical issues in HRPO post-approval submissions
  • Support the HRPO leadership in the conduct of noncompliance investigations and compliance inspections of extramural protocols
  • Assist in development and implementation of internal HRPO operating procedures and work instructions
  • Participate in performance improvement activities and working groups to improve and streamline the protocol review and approvals processes
  • Contract support for the Office of Research Protections, Human Research Protection Office US Army Medical Research & Development Command (USAMRDC)

Human Research Protection Specialist - Training (GS-13)

Department of the Navy
10.2018 - 09.2019
  • Company Overview: Office of Naval Research, Research Protections Division
  • Performed on-going institutional compliance monitoring of studies through headquarters level administrative reviews, component level administrative reviews, IRB minutes reviews and others as mandated by the SECNAVINST 3900 instruction document
  • Conducted assist visits and site inspections to Dept
  • Of Navy Human Research Protection Programs (DON HRPP) to assess their quality and effectiveness
  • Provided regulatory support and subject matter guidance as required
  • Participated in the design, development, and implementation of web-based educational events, programs, and materials for human research protection training throughout the DON to maintain compliance
  • Participated in the inquiries of allegations of non-compliance with human subjects from root cause analysis to resolution
  • Prepared reports and recommendations based on federal code of regulations, good clinical practice, DoD guidance and instructions to assist the Director, DON HRPP to identify and address new developments and unanticipated issues related to human subject’s protection
  • Office of Naval Research, Research Protections Division

Human Research Protection Compliance Analyst

Armed Forces Services Corporation (AFSC)
10.2017 - 10.2018
  • Company Overview: Contract support for the Department of the Navy, Human Research Protection Program Bureau of Medicine and Surgery
  • Conducted assist visits and site inspections to Dept
  • Of Navy Human Research Protection Programs (DON HRPP) to assess the quality and effectiveness of the programs and provide regulatory support and subject matter guidance as required
  • Prepared reports and recommendations based on federal code of regulations, good clinical practice, DoD guidance and instructions to assist the Director, DON HRPP to identify and address new developments and unanticipated issues related to human subject’s protection
  • Performed on-going institutional compliance monitoring of studies through headquarters level administrative reviews, component level administrative reviews, IRB minutes reviews and others as mandated by the SECNAVINST 3900 instruction document
  • Completed administrative reviews of command DoD-DON assurances and ensure execution of new and renewal assurance packages
  • Assisted with the development and implementation of internal standard operating procedures, and training and education materials
  • Contract support for the Department of the Navy, Human Research Protection Program Bureau of Medicine and Surgery

Program Regulatory Affairs Specialist

Henry M. Jackson Foundation (HJF)
12.2014 - 10.2017
  • Company Overview: Contract support for The Infectious Disease Clinical Research Program (IDCRP) Uniformed Services University of the Health Sciences (USUHS)
  • Coordinated and managed program regulatory affairs activities (pre-IRB review, scientific review, amendments, continuing review, final reports) related to the development and implementation of clinical research on multi-drug resistant infections, HIV/AIDS, influenza, and other infectious diseases relevant to the military
  • Served as program point of contact for interpretation and application of human subjects regulations and DoD (Army, Navy, DHA) policies and studies requiring HRPO review
  • Assisted with regulatory interpretation of activities that constituted Human Subject Research, Not Human Subject Research, Exempt or Quality Assurance/Quality Improvement activities
  • Reviewed research team determinations and documentation of protocol deviations, violations, and safety- related events (AEs, SAEs, etc.)
  • Created and maintained program regulatory standard operating procedures and other guidance documents
  • Coordinated research training activities for principal investigators and research personnel
  • Conducted site visits to ensure human subject protection and regulatory compliance procedures were followed
  • Provided study tracking metrics and reports to quantitatively measure review efficiency
  • Contract support for The Infectious Disease Clinical Research Program (IDCRP) Uniformed Services University of the Health Sciences (USUHS)

Human Subjects Protection Scientist

General Dynamics, Information Technology (GDIT)
06.2014 - 12.2014
  • Company Overview: Contract support for the Clinical Investigations Regulatory Office (CIRO) Office of Research Protections (ORP), US Army Medical Research & Materiel Command (USAMRMC)
  • Provided professional contract support for the Clinical Investigations Regulatory Office (CIRO) Director in the development, interpretation, and implementation of Cooperative Research and Development Agreements (CRADA), policies, procedures, and programs
  • Provided Headquarters Level Administrative Reviews (HLAR) on eligible protocols for regulatory compliance and quality assurance
  • Contract support for the Clinical Investigations Regulatory Office (CIRO) Office of Research Protections (ORP), US Army Medical Research & Materiel Command (USAMRMC)

CIRB Local Context Coordinator

The EMMES Corporation
08.2011 - 06.2014
  • Provided regulatory guidance and support to member institutions in the NCI National Clinical Trials Network on study submissions for cooperative group clinical trials
  • Served as main point of contact for assigned member institutions, investigators, research and clinical staff and administrators on local context regulatory issues
  • Engaged in the ongoing review of IRB submissions using the web-based platform

Project Coordinator

Chesapeake Research Review Inc.
08.2007 - 07.2011
  • Served as the main point of contact between the IRB and research institution study staff and the study Principal Investigator for designated studies
  • Administratively reviewed research protocols submitted by clients for Independent Review Board (IRB) approval in support of NDA, PMA, 510(k) and BLA and other FDA phase I-IV approval applications prior to IRB review
  • Worked with Institutional Review Board designees to secure approval on regulatory submissions
  • Prepared and released client correspondence including initial study approvals, amendments and continuing review approvals
  • Provided pre-reviewed on MEDWATCH Forms, IND Safety Reports and Serious Adverse Event Forms prior to submission to the IRB subcommittee member
  • Conducted 100% quality control on all documents to ensure the highest level of quality

Regional Document Quality Assurance Coordinator

Quintiles, Inc. [IQVIA]
10.2004 - 07.2007
  • Served as the systems administrator for the corporate Standard Operating Procedures (SOPs) Database
  • Designed and conducted system validation activities to ensure compliance with Federal Register (21 CFR Part 11) regulations
  • Performed helpdesk and remote user interface activities for internal database users
  • Generated, distributed, and performed archiving activities on SOPs and related proprietary documents
  • Maintained a database to track requests and completed controlled document distribution

Technical Information Specialist

Parallax, Inc. (renamed Energy Solutions Performance Strategies, Inc.)
09.2002 - 09.2004
  • Data entry into the FDA medical device electronic data capture system
  • Provided support for and resolution to client registration and device listing issues pertaining to Federal Register guidelines
  • Created and implemented more efficient data entry processes by designing workflow documents and identifying bottlenecks
  • Provided direct supervision of three data key operators

Program Coordinator

Aspen Systems Corporation (acquired by Lockheed Martin)
01.2000 - 06.2002
  • Processed initial requests for service and technical assistance from the U.S
  • Department of Housing and Urban Development (HUD) Community Development Block Grant (CDBG) office
  • Ensured proper oversight and compliance of regulations on open projects
  • Served as the principal liaison between HUD and Aspen Systems for communication pertaining to project modifications and deliverable deadlines
  • Served as the principal assistant to the project director of a national HUD training contract

Education

B.A. - Political Science

Mount Saint Mary’s University
Emmitsburg
01.1997

M.B.A. - Organizational Management

University of Maryland University College
01.2011

Skills

  • Microsoft Office
  • Windows Operating Systems
  • SharePoint
  • WebEx
  • Skype
  • Zoom
  • Microsoft Teams
  • Google Meet

Selected Continuous Education Activities

  • Human Subject Protection Seminar: Association of Clinical Research Professionals (2009).
  • CIP preparation course: Chesapeake Research Review, Inc. (2010).
  • Protecting Human Research Participants - The National Institutes of Health (NIH) Office of Extramural Research (2012).
  • Privacy Act and HIPAA Training: Ft. Detrick US Army Medical Research and Materiel Command (06/01/14).
  • Collaborative Institutional Training Initiative (CITI): Henry M. Jackson Foundation. GCP for Investigators and Key Research Personnel, R (2014); Department of the Navy (2017); Revised Common Rule (2019).
  • Continuing Education Certificate: Walter Reed Army Institute of Research Good Clinical Practice, Instructor-led Training (2015).
  • Continuing Education Certificate: Walter Reed National Military Medical Center, Human Research Protections Workshop (2016).
  • Electronic Institutional Review Board – Human Research Team Training (2018).
  • Public Responsibility in Medicine and Research (PRIM&R) Annual Conference on Ethical Research (regular attendee (Attended 2010, 2012, 2015, 2017, 2018).
  • PRIM&R Webinar – 'Risks in Social and Behavioral Research' (2019).
  • Northwest Association for Biomedical Research/Office of Human Research Protections Conference, Lynnwood, WA - 'New Research Landscapes' (2019.).
  • Grand Rounds – Research lecture series, Uniformed Services University of the Health Sciences.
  • Department of Defense Human Research Protection Training Days.
  • Army Human Research Protection Office Training Summit.
  • Seminar on Human Subject Research Ethics for Responsible Innovation using Federal Funds (SHERIFF).
  • Public Responsibility in Medicine and Research (PRIM&R) Annual Conference on Ethical Research. Virtual participant 2020.

Academic Membership

  • Member: Phi Kappa Phi Academic Honor Society.
  • Toastmasters, Inc. Rockville, MD

Timeline

Research Ethics and Compliance Officer

US Department of Defense
02.2022 - Current

Human Subjects Protection Scientist III/Team Lead

General Dynamics Health Solutions
10.2019 - 02.2022

Human Research Protection Specialist - Training (GS-13)

Department of the Navy
10.2018 - 09.2019

Human Research Protection Compliance Analyst

Armed Forces Services Corporation (AFSC)
10.2017 - 10.2018

Program Regulatory Affairs Specialist

Henry M. Jackson Foundation (HJF)
12.2014 - 10.2017

Human Subjects Protection Scientist

General Dynamics, Information Technology (GDIT)
06.2014 - 12.2014

CIRB Local Context Coordinator

The EMMES Corporation
08.2011 - 06.2014

Project Coordinator

Chesapeake Research Review Inc.
08.2007 - 07.2011

Regional Document Quality Assurance Coordinator

Quintiles, Inc. [IQVIA]
10.2004 - 07.2007

Technical Information Specialist

Parallax, Inc. (renamed Energy Solutions Performance Strategies, Inc.)
09.2002 - 09.2004

Program Coordinator

Aspen Systems Corporation (acquired by Lockheed Martin)
01.2000 - 06.2002

B.A. - Political Science

Mount Saint Mary’s University

M.B.A. - Organizational Management

University of Maryland University College

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John A. Morais