Ruth J. Green-Waite
Charlotte
Summary
Dedicated clinical research professional with a proven track record in conducting comprehensive studies while ensuring strict adherence to regulatory standards. Recognized for exceptional collaboration and adaptability within dynamic environments, fostering effective teamwork and innovative problem-solving. Expertise in protocol development and data interpretation enhances the ability to drive projects forward and achieve impactful results. Committed to advancing clinical research initiatives through meticulous attention to detail and a proactive approach.
Overview
44
44
years of professional experience
1
1
Certification
Work History
Contract Clinical Research Consultant
Self-employed
Charlotte, NC
09.1995 - Current
- Experience in Program Management, Study Management (US and EU), Auditing, Monitoring, and Data Management
- Assigned projects by various Sponsors and Contract Research Organizations
- Phases I-IV
- Experience with creating and/or providing input for document development (Protocol, CSR, Management Plans, CCGs, Source Documents, Study Logs)
- Experience with Vendor negotiation
- Experience with CRO oversight
- Extensive experience in monitoring and management of appointed sites from site selection to close-out
- Experience with blinded and unblinded monitoring
- Experience with overseeing monitors, co-monitoring with monitors to assure GCP and SOP compliance, and training new monitors to company standards and assessing competency
- Experience with site auditing in preparation for FDA audit
- Therapeutics areas include: Asthma and Allergy Autoimmune – Crohn’s Disease, RA, SLE Biologics – Monoclonal antibodies Cardiovascular – Veno-occlusive Disease Dermatology – Acne, Atopic dermatitis, Psoriasis, Seborrheic dermatitis Endocrinology – Type II DM ENT – Noise Induced Hearing Loss GI – GERD, GU, DU, IBS, Crohn’s Disease, Healthy Volunteers, Hematology/Oncology – Advanced Hematological Malignancies, Bladder, Breast, Choriocarcinoma, Glioblastoma, GTN, HSCT, ITP, Leukemia (ALL, AML, CLL), Liver, Lung, Lymphoma, Melanoma, Ovarian, Pancreatic, Prostate, RAS-Mutated Tumors, Renal Cell Carcinoma, Sarcoma, Solid Tumors
Men’s Health – BPH, Erectile Dysfunction
Metabolic – Leigh Syndrome, Obesity
Neurology – Alzheimer’s Disease, Epilepsy, Migraines, Multiple Sclerosis, Parkinson’s Disease, Spinocerebellar Ataxia
Pain Management – OA
Pediatrics – ADHD, Epilepsy, Depression, Leigh Syndrome, OCD, Acne, Psoriasis
Provocative Meals – GERD
Psychiatry – ADHD (adolescent, adult), Depression (pediatric, adult, elderly), GAD, OCD, PMDD, PTSD
Radiolabeling – Radiolabeled monoclonal antibodies
Respiratory – COPD
Rheumatology – OA, RA, SLE
Urology – Anemia in CKD, Kidney Dialysis, Renal Impairment
Urinary Device – Urinary Retention
Sponsor list: Abbott Laboratories, Akebia Therapeutics, Alizyme Therapeutics Ltd, Ambit Biosciences, Bellicum Pharmaceuticals, Inc., BioElectron Technology Corporation, Biogen Idec, BiPar Sciences Inc, Cadent Therapeutics, Connetics Corporation, Edison Pharmaceuticals, ENDO Pharmaceuticals, GlaxoSmithKline, Glaxo-Wellcome, Human Genome Sciences, Kanisa Pharmaceuticals, Keryx Biopharmaceuticals Inc, IDEC Pharmaceuticals, Immuneering Corporation, Influence Inc, InhibRx Biosciences, Macrochem Inc, MedDay Pharmaceuticals, Organon Inc, Parke-Davis, Peplin Operations Pty Ltd, Phytopharm plc, Purdue Pharma, Sanofi-Aventis, SmithKline Beecham Pharmaceuticals, Stiefel Laboratories, Sunesis Pharmaceuticals, TAP Holdings Inc, TRACON Pharmaceuticals, Watson Pharmaceuticals
Clinical Research Associate
Paragon Biomedical, Inc.
Irvine, California
01.1995 - 09.1995
- Responsible for the monitoring and management of appointed sites
- Therapeutics areas include Asthma and Allergy, Endocrinology, GI, and Neurology
Contract Clinical Research Monitor
Self-employed
Sebring, FL
12.1992 - 12.1994
- Assigned projects by various Contract Research Organizations
- Responsible for the monitoring and management of appointed sites
- Therapeutics areas include Asthma and Allergy, Endocrinology, GI, Neurology, and Urology
Clinical Research Associate
Western Reserve Care System
Youngstown, Ohio
09.1988 - 09.1992
- Head of the Department of Research
- Reported to the Senior Vice President, Medical Affairs
- Responsible for all overseeing research activities within the hospital system
- Served as Clinical Research Coordinator for all pharmaceutical drug trials
- Served as a Liaison between Western Reserve Care System, Youngstown State University and Northeastern Ohio Universities College of Medicine in Research Matters
- Assisted in the design, set-up, funding, data entry, and statistical analysis of research; formatted and edited manuscripts for publication for entire medical staff (attending physicians, residents, nurses, allied health professionals)
- Developed and implemented departmental policies and policies relating to the research process
- Planned departmental budget and monitored expenditures
- Selected, trained, supervised, and evaluated research department personnel
Limited Service Faculty
Youngstown State University
Youngstown, Ohio
03.1990 - 06.1992
- Taught Senior Level Research Methodology Class
- Department of Allied Health
Graduate Assistant
Youngstown State University
Youngstown, Ohio
09.1987 - 05.1988
- Prepared and taught various Biology classes and labs
- Department of Biology
Research Assistant
Youngstown State University
Youngstown, Ohio
07.1987 - 09.1987
- Assisted with research being done in one of the Biology labs
- Department of Biology
Laboratory Assistant
Youngstown State University
Youngstown, Ohio
02.1987 - 07.1987
- Assisted instructor with various Biology labs
- Department of Biology
Student Assistant
Northeastern Ohio Universities College of Medicine
Rootstown, Ohio
09.1983 - 01.1984
- Assisted Biochemistry Chairman with research and revision of class syllabus
- Department of Biochemistry
Laboratory Assistant
Youngstown State University
Youngstown, Ohio
09.1982 - 08.1983
- Assisted with laboratories in Physical Science and Biochemistry
- Department of Chemistry
Education
No Degree - Biomedical Sciences
Kent State University
Kent, Ohio06-1991
Master of Science - Cell Biology
Youngstown State University
Youngstown, Ohio08.1988
No Degree - Medicine
Northeastern Ohio Universities College of Medicine
Rootstown, Ohio06-1986
Bachelor of Science - Combined Sciences
Youngstown State University
Youngstown, Ohio06.1985
High School Diploma -
Champion High School
Warren, Ohio06.1981
Skills
- Comprehensive knowledge of clinical trials, FDA regulations, and ICH GCPs
- Strong verbal communication
- Strong attention to detail
- Proficient in troubleshooting
- Proficient in clinical document creation
- Proficient in Microsoft Office
- Proficient in Electronic Data Capture, CDMS, CTMS, and eTMF systems
Affiliations
- American Mensa
- Association of Clinical Research Professionals
- The Honor Society of Phi Kappa Phi
- Sigma Xi, The Scientific Research Society
Certification
Certified Clinical Research Associate through ACRP, 1999-11
Timeline
Contract Clinical Research Consultant
Self-employed
09.1995 - Current
Clinical Research Associate
Paragon Biomedical, Inc.
01.1995 - 09.1995
Contract Clinical Research Monitor
Self-employed
12.1992 - 12.1994
Limited Service Faculty
Youngstown State University
03.1990 - 06.1992
Clinical Research Associate
Western Reserve Care System
09.1988 - 09.1992
Graduate Assistant
Youngstown State University
09.1987 - 05.1988
Research Assistant
Youngstown State University
07.1987 - 09.1987
Laboratory Assistant
Youngstown State University
02.1987 - 07.1987
Student Assistant
Northeastern Ohio Universities College of Medicine
09.1983 - 01.1984
Laboratory Assistant
Youngstown State University
09.1982 - 08.1983
Bachelor of Science - Combined Sciences
Youngstown State University
No Degree - Biomedical Sciences
Kent State University
Master of Science - Cell Biology
Youngstown State University
No Degree - Medicine
Northeastern Ohio Universities College of Medicine
High School Diploma -
Champion High School
PUBLICATIONS
Walton RG, Hudak R, Green-Waite RJ. Adverse reactions to aspartame: Double blind challenge in patients from a vulnerable population. 1993 June, Biological Psychology.
EDUCATIONAL PROGRAMS AND SEMINARS
- Ethical Principles in Clinical Research, Webinar presented by ACRP, 2025-08-28
- A Comparison of ICH E6(R2) and ICH E6(R3), Webinar presented by ACRP, 2025-02-20
- CITI GCP (US FDA Focus) Certification 2023-06-01
- Good Clinical Practices Training, Webinar presented by ComplianceOnline, 2020-10-26
- Remote Oversight and Monitoring of Clinical Trials, Webinar presented by OWL Oncology Research, LLC, 2020-09-24
- Veeva Vault CTMS Train the Trainer, 2020-07-24 to 2020-07-27
- GxP Compliance for Virtual Companies, Webinar presented by TRACON Pharmaceuticals, 2020-07-24
- Applying the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, Webinar presented by OWL Oncology Research, LLC, 2020-07-23
- Veeva CDMS for CRAs, 2020-05-28
- Quality Check Training, Webinar presented by Momentum-Pharma, 2020-05-27
- IRECIST Workshop, presented by ACRP, Part 1 – 2020-03-11, Part 2 – 2020-04-01
- CITI GCP FDA Certification 2019-08-24
- CITI GCP ICH Certification 2019-08-24
- CITI GCP FDA Certification 2017-06-23
- CITI GCP ICH Certification 2017-06-23
- ACRP Risk-Based Monitoring: The Essentials for CRAs, 2016-02-24
- Real Time Data Capture: Impact on Sites, presented by the Greater Charlotte Chapter of ACRP, 2016-04-23
- ACRP GCP for the Experience CRA, 2015-05-22
- Barnett GCP for Clinical Trials Exam, passed 2011-09-14
- Reporting of Serious Breaches of GCP, 2011-08-08
- Management of Investigational Medicinal Product for Clinical Trials, 2011-07-05
- FDA regulations changes on Informed consent elements effective 2011-03-07, 2011-03-14
- FDA regulations – Summary of Changes effective 2011-03-28, 2011-03-14
- Investigational Product, Randomization, and Unblinding & Source Documents and Case Report Form Completion, 2011-02-28
- Clinical Investigator Obligations & Qualifications, Resources, IRB/IECs, 2011-02-28
- Subject Informed Consent & Protocol Compliance, 2011-02-28
- Safety Reporting, Financial Disclosure & Study Close-out, Trial Termination, and Record Retention, 2011-02-28
- Non-compliance, Scientific Misconduct and Fraud & Monitoring and Preparing for Audits and Inspections, 2011-02-28
- Overview of ICH Good Clinical Practice, 2011-02-28
- CITI Good Clinical Practice Curriculum, 2010-05-15
- Online Oracle Database, v4.5.1, Classic RDC training, 2007-05-03
- Online Oracle Database, v4.5.1, PDF RDC training, 2007-04-27
- Insider Trading course, sponsored by Connetics Corporation, 2006-04-29
- HIPAA Training, sponsored by GlaxoSmithKline, 2003-03-26
- Oncology Training, sponsored by GlaxoSmithKline, Philadelphia PA, 2002-02-19 to 2002-02-20
- HIV Training, sponsored by GlaxoSmithKline, Las Vegas NV, 2001-10-17
- Remote Data Management Training, sponsored by SmithKline Beecham, Philadelphia PA, 1999-10-21
- Monitor Training Program, hosted by Paragon Biomedical Inc., Irvine CA, 1995-02-13 to 1995-02-14
- Covey Time Management Seminar, Irvine CA, 1995-02-13
- Collaborative Research Workshop, Rootstown OH, 1992-08-25
- Interviewing and Selecting Leadership Development Program, 1992-06-02
- Time and Attendance Seminar, 1991-04-12
- Dun & Bradstreet Seminar on Lotus 1-2-3, 1990-09-26
- Dun & Bradstreet Seminar on DOS, 1990-09-26
- Budget Planning Seminar, 1990-06-28 & 1991-06-26
- Research Grant Applications: Maximizing Your Potential, 1989-01-23
- Stimulating Clinical Research at the Teaching Hospitals of a Community Based Medical School, 1988-10-05
COMMITTEE APPOINTMENTS
- Western Reserve Care System, Youngstown OH Clinical Research Committee, 1988 – 1992 Institutional Review Board, 1989 – 1992 Teaching and Research Committee, Beeghly Oaks Nursing Home, 1989 – 1992
- Northeastern Ohio Universities College of Medicine, Rootstown OH Geriatric Medicine/Gerontology Research Subcommittee, 1989 – 1992 Research Administrators Group, 1989 – 1992
INVITED LECTURES
- Tools for Completing NHL eCRFs, presented September 20, 2008 at a Biogen Idec Investigator’s Meeting, Sydney, Australia
- Tools for Completing NHL eCRFs, presented September 13, 2008 at a Biogen Idec Investigator’s Meeting, Las Vegas, NV
- Tools for Completing NHL eCRFs, presented July 19, 2008 at a Biogen Idec Investigator’s Meeting, Washington, DC
- Tools for Completing/Monitoring NHL CRFs, presented June 28, 2008 at a Biogen Idec Investigator’s Meeting, Frankfurt, Germany
- Good Clinical Practices, presented January 2, 2003 to DMI Healthcare Group, Largo FL
- Good Clinical Practices, presented March 13, 1999 to DMI Healthcare Group, Largo FL
- Statistics in Medicine, presented 1990 to house staff at Youngstown Osteopathic Hospital, Youngstown OH
- Statistics in Medicine, presented October 7, 14, 21, and 28, 1989 to Western Reserve Care System, Youngstown OH
MASTER’S THESIS
Green RJ. 1988. The analysis of methionine and leucine enkephalins in relationship to the immune response in trauma patients by high pressure liquid chromatography and microspectrophotometric techniques. M.S. thesis, Youngstown State University.