Curriculum Vitae
Jane A. Green, Ph.D., CCRA________________________________________________
Sandy Springs, GA 30350
770-***-**** (H) 404-***-****(O)
*/**** – Current
President, Morley Research Consortium (MRC), Atlanta, GA
A research consortium dedicated to the assisting research organizations in their CRO endeavors, education, training, auditing, monitoring, business development, financial management, regulatory or IRB auditing. The Consortium also consults with IRBs, hospitals, private clinics, for the management of their regulatory departments, marketing and development of their research program, and quality assurance for their clinical research coordinators and or monitors. The Consortium provides the Research component for large Compliance Programs that require this element in their overall compliance program. The Morley Consortium provides formal training programs for CRC’s, CRA’s, Site Management staff, Regulatory departments and Physician researchers and provides development of education/training programs for specific organizations. The Consortium has developed SOP templates for Clinical Sites, IRBs, and Device Sponsors.
07/09 – Current
Chief Compliance Officer, Opus Institutional Review Board
Oversees the Opus compliance efforts, functioning as an independent and objective body that reviews and evaluates compliance issues/concerns within the organization. The position ensures the Board of Directors, management and employees are in compliance with the rules and regulations of regulatory agencies, that company policies and procedures are being followed, and that behavior in the organization meets the company’s standards of conduct. The Corporate Compliance Officer acts as a channel of communication to receive and direct compliance issues to appropriate resources for investigation and resolution. The Chief Compliance Officer or designee develops, initiates, maintains, and revised policies and procedures for the general operation of the compliance program and its related activities to prevent illegal, unethical, or improper conduct. The Officer responds to alleged violations of rules, regulations, policies, procedures, and standards of conduct by evaluating or recommending the initiation of investigative procedures.
10/91 – 1/2002
President and CEO, American Medical Research Institute, Inc., Atlanta, GA
Formerly the Atlanta Center for Cancer Research & Education. An oncology research organization designed to provide research opportunities to community physicians. Monitored and provided QA/QC for all staff and clinical operations. Project
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Management of approximately 20 studies at all times for multiple sponsors and multiple clinics. Developed and maintained the Regulatory Department for 16 individual clinic sites. Established Standard Operating Procedure guidelines for all sites and for the Institutional Review Board. Business development and supervision of 120 + oncology physician network in southeast US. Monitored over 16 clinics in 7 states to include physicians and research staff for GCP compliance. Managed team of over 60 research nurses and related research staff. Designed workshops for coordinator and monitoring training, investigator training, and contract negotiations.
4/90 – 10/91
Executive Director, the Atlanta Center for Cancer Research and Education, Atlanta, GA
A non-profit research organization formed to spread clinical trials into rural community areas throughout the entire state of Georgia. After networking the state of Georgia I expanded this pharmaceutical research network into a comprehensive network throughout the southeast. The Atlanta Cancer Research & Education was sold and became the American Medical Research Institute, Inc. listed above.
12/88 – 4/90
Director of Clinical Oncology Programs, Georgia Oncology Hematology Clinic, Atlanta, GA
Private practice clinic starting up a research department. Implemented all aspects of initial operations and management of patients
6/88 – 12/88
Coordinator of Affiliated Programs, University of Kentucky, Lexington, KY
Instituted first planned affiliate consortium for clinical research programs. Program utilized doctors from Kentucky, Tennessee, Georgia, Alabama and Florida.
6/86-6/88
Clinical Research Associate, University of Kentucky, Lexington, KY
Protocol Office-CRA for Cancer Center, University Hospital, Veterans Hospital and Out-Patient Clinic.
7/84-6/96
Patient Service Coordinator, University of Kentucky, Lexington, KY
Coordinated oncology in-patient unit services.
12-72 – 1/74
Supervisor, Lexington Police Department, Lexington, KY
Complaint Desk Supervisor and female undercover jobs
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6/70-12/72
Special Agent, Federal Bureau of Investigation, Washington, D.C.
Assisted in undercover FBI operations dealing with national security issues.
EDUCATION
University of Kentucky Stanford University
Lexington, KY Palo Alto, CA
1972-1974 and 198*-****-**** – 1976
Clayton College, Birmingham, AL Duke University Medical School
BS in Natural Science, 1992 1995 – Certificate of Clinical Research
Clayton College, Birmingham, AL Clayton College, Birmingham, AL
MS in Natural Science, 1997 Ph.D. in Natural Science, 2001
PRESENTATIONS
Training workshops for data managers “Following Your Patients”, Lexington, KY 1987 and 1988
Nursing curriculum for Northside Hospital, Atlanta, GA: “What are Clinical Trials” and
“The Nursing Role in Clinical Trials” 6/90 and 6/91
RN Education Programs – Cancer Specialist of Georgia, Atlanta, GA: “Clinical Trials in the Community Physician’s Office”, “An Office Nurses Role in Clinical Trials” 9/90, 3/91, 6/91
SoCRA Annual Meeting: “The Future is Bright: Accreditation and Other Trends for the 90s”, September, 1992, Cincinnati, OH
Southwest Oncology Group (SWOG) Spring Meeting: “Reimbursement Issues for Clinical Trials”, April 1993, San Antonio, TX
Singletary Oncology Center, Thomasville, GA; “Clinical Trials for GYN Physicians, 6/93
Department of Public Health, Georgia Districts: “How to Obtain Grant Money for Research”, 11/94, Atlanta, GA
Georgia State Legislature: “Research in Your Own Backyard”, 11/95, Atlanta, GA
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Department of Public Health, Georgia Districts, Atlanta, GA: “Breast Cancer Update, Funds Available”, March 1996
Women’s Policy Group, Inc, Atlanta, GA: “Medical Clinical Trials: What Georgia Women Need to Know”, June 1996
National Pharmaceutical Council: “Research in Your Backyard” Programs, presented at St. Vincent’s Hospital, Jacksonville, FL 4/97
National Pharmaceutical Council: “Research in Your Backyard” presented at VRG, International, Dallas, Texas 6/97
ACRP (Association for Clinical Research Professionals): “Personal Growth for Research Professionals”, 1/98
Brunswick Georgia Physicians Association: “Prostate Cancer – New Research Opportunities, March. 1998
South Georgia Medical Center, Valdosta, GA: “The Importance of Research in a Community Hospital”, October 28, 1998
American Society of Hematology (ASH): Novartis Pharmaceuticals meeting: “How to Develop Community Physician Practices into Quality Research Facilities, Dec, 1998
Kentucky Oncology Meeting, Lexington, KY “How to Start up a Cancer Research Program in the Community Setting, March, 1999
Tampa Bay Area Urology Meeting: Prostate Cancer – New Research Studies”, May, 1999
Clinical Investigator Training Workshops: South Georgia 9/99, Central Georgia, 12/99, North Florida 2/2000, Central Florida, 4/2000
Clinical Research Coordinator Training Workshops, Atlanta, GA, 10/99, 8,2000, 9/2001, 10/2001
“Designing an Effective Individual Training Matrix for an Individual Employee” BioPharmaceutical Training Program to Meet FDA Requirements, IIR, Princeton, NJ 11/2001
“Building Successful Training Programs For External Investigators”, BioPharmaceutical
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Training Program to Meet FDA Requirements, Princeton, NJ 11/2001
National Women’s Health Resource Center – Medical Advisor for Clinical Research Trials, January 2002
Atlanta Area Chapter of National Association of Clinical Research Professionals – CRC Level 1 and 2 Workshops 4/2001, 6/2001, 9/2001, 11/2001, 6/2002, 8/2002, 2/2003, 6/2004, 1/2005, 6/2005, 1/2006.
Investigator as a Sponsor, University of Cincinnati, Cincinnati, OH 9/2009
Risk Management for Investigator Initiated Research, Senior Research Administrators, October 2010, Chicago, IL
Investigator Initiated Research, Southeast Medical Device Association, Atlanta, GA 1/2011
Investigator Initiated Research Case Study Presentation, MAGI, Las Vegas, NV, 10/2010
AWARDS
Top Five Clinical Programs in America by NSABP (National Surgical Association Breast and Bowel Project), 1991 and 1992
PROFESSIONAL ASSOCIATIONS
National Pharmaceutical Council – Advisory Research Consultant 1995 – present
Association of Clinical Research Professionals – National Member since 1994
Atlanta Chapter President of ACRP (Association of Clinical Research Professionals)
1998 – 7/2002
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Society of Clinical Research Associations (SoCRA) – President-Elect 1995, Member of the Board of Directors 1989 – 1996. Chairperson of the Education Committee, 1992 – 1994. Certified CRA 1989.
Steering Committee for designing a Certificate of Completion program for Clinical Research Associates at Duke University, 1993 – 1996.
Susan G. Komen Breast Foundation – Board of Directors – January 1992 – 1996
Research America – 1994 – 1998
ASCO (American Society of Clinical Oncology) – 1996 – current – Affiliate Member
Healthcare Compliance Association (HCCA) – 2006 – current – Member
PRIM&R Advancing Ethical Research Conference – 2009 – current - Member
10/11