Sr. CRA, Study Manager, and Nurse

JANICE L. BERRYMAN

**** ******** **.

Atlanta, GA 30319

Cell: 404-***-****

E-Mail – **********@***.***

Experience: Director of Clinical Monitoring and Site Management / Senior CRA

****-**** *NC Research – Senior Clinical Research Associate – Responsible for monitoring a

variety of clinical trials. Assures adherence to Good Clinical Practice, Investigator

integrity and compliance with all study procedures.

Primary responsibility is for site management and performance, including

documentation. Site management activities include all in-house and on-site

monitoring for all visit types. Therapeutic Focus – CNS studies

2009 - 2010 Full Time Position with Banyan Biomarkers, Inc. in Alachua, FL - Director of Clinical Monitoring and Senior CRA

1991-2009 Independent Consultant working on all Phases of Clinical Trials, responsible for site management, reporting, and resolution of queries. Areas of monitoring have included, but not limited to: Cardiovascular, CNS, Bi-Polar, Insomnia, BPH, MS, Oncology/Aids, HIV, Infectious Disease, Endocrine, Inhaled Insulin, Diabetic Studies, Dermatology, Hypertension, Stroke Prevention, Lipid Lowering, A-Fibrillation, Cardiac Device, Dental, Urinary Incontinence, Women’s Health, Pediatrics, Urology, Inpatient Post- Operative Ileus, Pain Management also Pain Management with Opioids, Rheumatoid and Osteoarthritis, Allergy, Gastrointestinal – GERD, ADHD, Cardiac Device, Orthopedic Device ( Cardiac and Orthopedic) COPD, Cosmetic Surgery , Depression, Cataract and Eye Care, Ophthalmology, Third Party Auditing and Sponsor Auditing, Psychiatric Disorders, Prostate Cancer, Breast Cancer, Lung Cancer. Monitored all phases of clinical trials and have conducted visits from Site Evaluation through Close-Outs. Phase I Pain studies, Phase I Women’s Health and Phase I CNS Studies, Hereditary Angioedema, Intra-gastric Procedures and Balloon, Gastric Band Device, Device Delivery Systems. Project Manager for KimberlyClark ‘s Phase II and III surgical device studies responsible for International Sites including Brazil, Singapore, Mexico, Chili, as well as US Sites.

2009 - Present Full Time Position with Banyan Biomarkers, Inc. in Alachua, FL - Director of Clinical Monitoring and Site Management and Senior CRA

• Monitored clinical research studies in various phases according to GCP regulations and Sponsor Standard Operating Procedures.

• Responsible for overall site management for assigned sites including written and verbal communication, scheduling monitoring visits, monitoring visit reports and resolutions of queries.

• Involved with all aspects of assigned projects including, but not limited to, attendance at all project related meetings, development and maintenance of Monitoring Data Review Guidelines, preparation of SAE reports and review of data edits in preparation for clean database.

• Involved with all aspects of assigned projects including, but not limited to, attendance at all project related meetings, development and maintenance of Monitoring Data Review Guidelines, preparation of SAE reports and review of data edits in preparation for clean database.

• Responsible for long term cardiovascular and oncology research studies at clinical research sites through the U.S. and Canada. (See Attachment to CV for detailed therapeutic areas and phases.)

1985-1991 Midwest Regional Manager/ Sales Representative

Major Pharmaceutical companies: (Contract Positions)

Bristol-Myers Squibb, Ortho McNeil, Rhone-Poulenc Rorer, Whitehall Laboratories

• Promoting new prescription drugs to hospitals and physicians.

• Responsible for training and managing a sales force of up to 50 representatives.

1981-1985 Staff Nurse - Newborn and Special Care Nurseries

Bethesda Hospital, Cincinnati, Ohio

Childbirth Educator

Northern Kentucky University, The Christ Hospital and Thomas More College

1978-1981 Staff Nurse - Transplant and Dialysis Unit

University Hospital, Cincinnati, Ohio

1972-1974 Charge Nurse - Psychiatric Unit

St. Elizabeth Hospital, Covington, Kentucky

Education: St. Elizabeth Hospital – Diploma Nursing Program

William Gebhardt Art Institute - Cincinnati, Ohio

Interior Design - BA

Atlanta National Hypnotherapy Institute – Atlanta, Georgia

Received certification in Clinical Hypnotherapy

Boston MASS General – Hypnotherapy Certification Program

Hebrew Union College– Cincinnati, Ohio

Hebrew Union College - New York, New York

Memberships: Sales Achievers, Leaders and Entrepreneurs of Cincinnati

National Association of Sales Professionals

National Association of Female Executives

Metro Atlanta Chamber of Commerce

Northern Kentucky Heritage League

Atlanta Society

Personal: International Consultant for Impressions International, Inc.

President and CEO

International Consultant for corporations and executives who travel to Japan and work for Japanese or other companies who deal in the international marketplace.

Previous Instructor at Northern Kentucky University

(Japanese Protocol, Business Negotiating, Culture and Business Etiquette)

Certified Clinical Hypnotherapist

Private practice located in the Buckhead area of Atlanta.

Published Author

Counselor

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