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Medical Writer / Clinical Trial Manager

Location:
Reisterstown, Maryland, United States
Salary:
$45 - 75/hr
Posted:
January 23, 2017

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Kenyatta Meticeo Cosby, M.D.

Medical Writer / Scientific Communicator

acyfj0@r.postjobfree.com

**** ***** ******, *********, ********, 21215

301-***-**** (cell)

OBJECTIVE

I am a Physician Scientist with over ten years of healthcare and medical research experience. I am seeking an exciting permanent medical writing opportunities to expand my medical / scientific communication background. I have a strong track-record that demonstrates my ability to develop a variety of compelling clinical, educational and scientific materials for governmental agencies, healthcare administrators and research professionals.

Key assets:

Excellent oral and written communicator with knowledge of database querying and large data management.

Great understanding of drug development, clinical and outcome study design, interpretation of results from Phase I-III

studies, and FDA’s INDs and NDAs processes including human research regulations (CFR; FDA and ICH guidance; EU

requirements). Also able to prepare clinical study reports and status reports.

Strong ability to read / comprehend complex legal business documents (contracts).

• Strong ability to work in a team-oriented environment while maintaining a sense of integrity and confidentiality

while managing multiple projects in a fast-paced environment, with changing priorities and deadlines.

• Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, and other

clinical regulatory documents in line with expectations.

Strategic content developer: Peer-reviewed articles, scientific products, web content, executive summary,

poster, abstract, news article, newsletters with proficient interpretation of scientific research.

Experience in preclinical / translational science processes which includes safety oversight of clinical trials.

Superb strategic and organizational skills with a strong sense of accountability and commitment to excellence.

Therapeutic area of interest: Cardiovascular/Nitrite-NO, Imaging, Neurology, Hematology, Oncology, Cardiology and Mental Health Disorders.

Language: English (Native, Fluent) and Mandarin Chinese (Beginner)

Impact on Science

The first, via clinical trial, to show that at near physiological conditions, nitrite under hypoxic conditions play a relevant role in regulation of vascular function in the presence of deoxygenated hemoglobin in human volunteers. [Nature Medicine- Nov 2003: 9(12); pp. 1498-1505]- This article has been cited over (1500 times). This work was conducted at NHLBI / NIH.

The first, to show a newly discovered physiological function of hemoglobin as a nitrite reductase that releases nitric oxide and leads to hypoxic vasodilation. This work was conducted at the National Heart Lung Blood Institute/ NIH.

The first to show a novel stem cell delivery/tracking system with Barium/Alginate utilizing microencapsulation technology (Stem Cells- 30:6.1286-1296 June 2012). This work was conducted at Johns Hopkins University School of Medicine

The first to formulate Diazeniumdiolates (This is a Nitric Oxide prodrug) in Sodium Alginate. (Manuscript in progress). This work was conducted at the National Cancer Institute/ NIH.

In (2010), 15 articles was selected (over a 15 year period) by the Nature Publishing Group which includes-[K. Cosby- Nature Medicine. Nov 2003:9 (12); pp. 1498-1505] and designated as a (Landmark Article) and placed in their newly created section Nature Medicine Classic Collection.

Professional Profile:

General - Exceptional leadership, communication (oral/written), analytical and problem resolution skills. This includes thriving in independent / collaborative environments with a strong ability to create a cooperative team spirit.

Team Work – Balances team and individual responsibilities; able to build morale and group commitments to goals and objectives; focuses on solving conflict; maintains confidentiality; also, remains open to new ideas.

Technical Skills – Ability to read, analyze and interpret scientific and/ or governmental regulations.

Clearly draft reports, business correspondence with strong attention to detail in a timely manner.

Seek accuracy and thoroughness; always look for ways to improve work and promote progress.

Diversity –Shows respect and sensitivity for personal and cultural differences. Values multiple viewpoints and is sensitive to factors (race, gender, age, culture, and religion) that may affect team behavior and feelings.

Computer Skills- MS Word, Excel, PowerPoint, Outlook, SPSS, and SharePoint.

Education/ Certification/ Training:

Master of Health Sciences in Clinical Research, (M.H.Sc.), Duke University School of Medicine and NIH Clinical Center, Bethesda, MD, On-going

INNoVATETM Biotechnology Entrepreneurship Certificate, Johns Hopkins University - Carey School of Business, Rockville, MD, Dec 2010

Leadership & Management in the Life Sciences Graduate Certificate, Johns Hopkins, Carey School of Business, Baltimore, MD Jul 2007

Doctoral of Medicine Degree, (M.D.), Howard University College of Medicine, Washington, DC June 2002

Bachelor Degree, (B.S.) General Science (Biology) & Minor Chemistry, with Honors [GPA = 3.7] Coppin State University, Baltimore, MD, May 1994

Professional Work Experience:

Medical Writer (Contractor)- Mometrix Media LLC: (01/13 – Present)

Beaumont, TX

Actively participated in medical writing and cross-functional project teams by in assembling, formatting, and proofreading figures, tables and content for manuals, Test preps, textbooks and research studies.

Technical expertise in Microsoft Office and familiarity with SharePoint and concepts of structured content management.

Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.

Create drafts of new technical or regulatory documents using existing examples, templates or reports.

Clinical Advisor- New Providence Healthcare Associates, Inc: (03/15 – Present)

Marlow Heights Medical Center, Temple Hills, MD

Assist Dr. Shanique Cartwright, M.D. with community wellness medical plan.

Created strategic plan for triaging medical patients and formatting/proofreading/ grafting clinical reports.

Current patient treated: Diabetes, stroke rehab, chronic pain, depression, OCD, schizophrenia and bipolar disorders.

Guest Researcher/ Medical Writer- National Cancer Institute, Frederick, MD (10/09 – 08/15)

Chemical Biology Laboratory-Drug Design Selection:

Prepared, with minimal supervision, a subset of clinical regulatory documents (e.g., CSR, IRB, clinical sections of IND) according to guidelines and international regulations.

Managed medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings using regulatory templates in Microsoft Word.

Support the R&D teams in tracking document completion, data verification strategies and completion of edits.

Project manager for formulation process of small molecules, anti-cancer drug (i.e. Diazeniumdiolates).

Created strategic plan to commercialize Diazeniumdiolates for the treatment of Cancer, CHF and Wound Healing.

Re-designed website to increase marketability of laboratory intellectual property.

Provided material support and editing for compliance with oversight committee and site-visit review.

International Scientific Advisor- Tongji Hospital, Tongji Medical College: (Consulting) (09/12 – 02/15)

Huazhong University of Science & Technology, Wuhan, China

Designed and development of scientific training program with George Washington University School of Medicine.

Draft/edited institutional agreements and served as liaison to international negotiations

Assisted with surgical manuscript proofreading and clinical research design in collaboration with Xiao-ping Chen, MD, (Professor and Chairman of Surgery) and Qian Chen, M.D., Ph.D. (Clinical Associate Professor Division of Gastroenterology, Department of Internal Medicine).

Created drafts of technical/regulatory documents using existing examples and templates for assembling, formatting, and proofreading document content.

Scientific Liaison- Bio-Trac,Inc at the Foundation for Advanced education in the Sciences, (09/09 – 02/15)

The National Institutes of Health, Bethesda, MD

Draft /design/ advertise scientific training program (Junior Scientist Training Program).

Created strategic partnership with academic institutions and pharmaceutical companies.

Developed partnerships with scientific and health authorities worldwide.

Supported expansion activities to serve new geographic areas/populations (i.e. China, Japan, Saudi Arabia)

Medical Writer (Consultant)- Centers for Disease Control and Prevention: (01/09 – 12/09)

Atlanta, GA

Commissioned by Charlotte D. Kaboré, MS, MPH, MCHES, Lieutenant, U.S. Public Health Service Commissioned Corps, Arthritis, Epilepsy, and Well-Being Branch, Division of Population Health, National Center for Chronic Disease Prevention and Health Promotion

Drafted and edited medical writings for Small Media Campaign to increase Screening for Breast and Cervical Cancer and to assess immunization Information System (IIS) Data in Oklahoma for pregnancy risk assessment monitoring.

Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.

Executive Director- EXPOSURE Program, Coppin State University, Baltimore, M.D (8/07- 9/13)

Interim Director, Center for Undergraduate Research, Associate Professor of Science

Negotiated - Partnership between the National Institutes of Health (NIH), Coppin State University (CSU), and Johns Hopkins School of Medicine (JHSOM).

Drafted and marketed medical brochures, manuals, posters, newsletter articles, abstracts, web-site content and protocols.

Research Fellow, Johns Hopkins Medical Institute, Baltimore, MD (4/06 - 6/08)

Cardiovascular/MRI and Cell Engineering Laboratory:

Managed activities related to planning, execution and reporting of clinical project.

Conducted micro-encapsulation process of mesenchymal stem cells with Sodium alginate/Barium/PLL.

Drafted protocol submissions and lead implementation of approval process.

Prepared and maintained study documents for compliance with the FDA, IRB and sponsors requirements which included safety reports, protocol deviations and FDA filings.

Present clinical data objectively in a clear, concise format in keeping with industry guidelines.

Research Fellow/ Clinical Trial Manager, National Institute of Health, Bethesda, MD (8/02 - 7/03)

Cardiovascular Laboratory: NHLBI- NIH

Project manager of FDA-approved Phase- I &II, Cardiovascular Clinical Trial. (Studied the vasodilatory effects of nitric oxide and metabolite, nitrite, on peripheral vasculature- namely brachial artery and antecubital vein).

Drafted / coordinated IRB submissions and lead implementation of approved studies.

Prepared and maintained approved studies for compliance with the FDA, IRB and sponsors requirements which included drafting INDs, Safety Reports, protocol deviations and FDA filings including subject narratives.

Drafted informed consent and HIPAA authorization, conduct intake interviews, and pre-evaluated enrolled subjects.

Manager of Safety, Efficacy, and adverse events in clinical study.

Prepared and reviewed manuscripts for publication to various National and International Journals.

HONORS/ SCIENTIFIC HIGHLIGHTS

Website Design: Chemical Biology Laboratory, National Cancer Institute-NIH, Frederick, MD; http://star.ncifcrf.gov/nitricoxide/default.aspx. and http://star.ncifcrf.gov/nitricoxide/thanks.aspx

Faculty of 1000 Biology: Evaluation for Cosby K et al Nat Med 2003 Dec 9 (12):1498-505. http://www.f1000biology.com/article/id/1016744/ Factor (9.0)- Exceptional

Hopkins Researcher Develop Novel X-ray System for Tracking the Delivery and Distribution of Stem Cells”,www. hopkinsmedicine.org/ Press_Releases/2007/03 25_07.html.

Research Protocol Development:

NIH - National Heart Lung Blood Institute (NHLBI), Cardiovascular Branch: National Institutes of Health.

Associate Investigator to Richard O. Cannon, M.D. - Determination of Nitrite as a Source of Bioactive Nitrite Oxide in Human Subjects: (03-H-0020). Closed (2002) [Phase I]

Co- Investigator to Yukitaka Shizukuda, M.D., Ph.D., FACC, FACP.-Characterization of Cardiac Function in Patients with Hereditary Hemochromatosis Who are New York Heart Association Functional Class I: (03-H-0282) Closed (2002) [Phase II]

Advisory Investigator to Yukitaka Shizukuda, M.D., Ph.D., FACC, FACP.- Hematochromatosis as an Indicator of Future Coronary Artery Disease. (June 2005 – January 2006). [Phase I]

JHU - Department of Radiology and Radiological Sciences: Johns Hopkins University School of Medicine

Associate Investigator to Dara L Kraitchman, VDM,PhD. A Novel Radio-opaque barium/alginate Microencapsulation Technique for Allogeneic Mesenchymal Stem Cell Delivery and Localization: Closed (2006-07)- RO1 HL073223 (CUFS678-2355)

Advisory Investigator to Dorota A. Kedziorek, M.D. MR-Guided Stem Cell Arteriogenic Therapy in a Rabbit Hindlimb Ischemia Model. (2007)

Advisory Investigator to Grigorios Korosoglou, M.D. Positive Contract MR- Lymphography Using Inversion Recovery with ON- Resonant Water Suppression (IRON). (2008)

NIH - National Cancer Institute-Frederick (NCI): National Institutes of Health.

Guest Investigator to Larry Keefer, Ph.D., - Synthesis of Nitric Oxide (NO)-Releasing Microcapsules from Diazeniumdiolates: Closed (June 2015)

Selected Peer-reviewed Publications & Research Presentations

Publications

1)Accelerated Carotid Artery Disease After High-dose Head and Neck Radiotherapy: Is there a role for routine carotid duplex surveillance? B.J. Carmody, M.D., S.Arora,M.D., R.Avena,M.D., K.Cosby,B.S., and A.N.Sidawy, M.D. J Vasc Surg, 1999;30:1045-51.

2)Folic Acid Inhibits Homocysteine-induced Proliferation of Human Arterial Smooth Muscle Cells. B.J.Carmody, M.D., S. Arora,M.D., R. Avena, M.D., K.Cosby, B.S., and A.N. Sidawy.M.D. J Vasc Surg 1999; 30:121-8.

3)Thiamine (Vitamin B1) Protects Against Glucose and Insulin-mediated Proliferation of Human Infragenicular Arterial Smooth Muscle Cells. R.Avena,M.D., S.Arora,M.D., B.J.Carmody, M.D., K.Cosby,B.S., and A.N.Sidawy,M.D. Ann Vasc Surg 2000;14:37-43.

4)(Abstract) Nitrite Reduction to Nitric Oxide By Deoxyhemoglobin Vasodilates the Human Circulation. Mark T. Gladwin, Kenyatta Cosby, Kristina Partovi, Sabrina Martyr, Christopher D. Reiter, Gloria Zalos, Alan Schechter, Richard O. Cannon III. Circulation- Supp IV, Oct 2003: Vol 108; No 17, IV-20 & 21.

5)Nitrite Reduction to Nitric Oxide By Deoxyhemoglobin Vasodilates the Human Circulation. Kenyatta Cosby, Kristina Partovi, Jack H. Crawford, Rakesh P. Patel, Sabrina Martyr, Christopher D. Reiter, Benjamin K.Yang, Myron A. Waclawiw, Gloria Zalos, Xiuli Xu, Kris T. Huang, Howard Shields, Daniel Kim-Shapiro, Alan Schechter, Richard O. Cannon III. and Mark T. Gladwin. Nature Medicine. Nov 2003: 9(12); pp.1498-1505.

6)(Abstract) Novel Function of Human Hemoglobin as a Nitrite Reductase Regulates Nitric Oxide Homeostasis and Hypoxic Vasodilation. Mark T. Gladwin, Kenyatta Cosby, Kristina Partovi, R.P. Patel, J.H. Crawford, D.B. Kim-Shapiro, Alan Schechter, Richard O. Cannon. Blood: 102; 11, 255A-255A. November 16, 2003.

7)Encapsulated X-ray Visible Stem Cells for Arteriogenic Therapy in Peripheral Arterial Disease. D.L.

Kraitchman, D.A.Kedziorek, W.D. Gilson, K.M.Cosby, G. Huang, B.P.Barnett, B Kohl III, JWM Bulte and LV

Hofmann. J Vasc Intervent Rad 19(2) supp-1: pg S67;February 2008

8)X-Ray-Visible Microencapsules Containing Mesenchymal Stem Cell Improve Hindlimb Perfusion in a Rabbit

Model of Peripheral Arterial Disease. Dorota A. Kedziorek, Lawrence V. Hofmann, Wesley D. Gilson, Kenyatta M.Cosby, Bernhard Kohl, III, Brad .Barnett, Brian Simons, Piotr Walczak, Jeff W.M.Bulte, Kathleen Gabrielson, Dara L. Kraitchman. Stem Cells. 30:6.1286-1296 June 2012.

9) Whose Using the NCI at Frederick Scientific Library? Kenyatta Cosby. Inside The Library 9:3; summer 2014.

10) Novel Technology and the War against Cancer. A New Tool in Nitric Oxide (NO) Research: Synthesis of NO-

releasing Microsphere for xtended Drug Delivery and Site Localization. Kenyatta Cosby, Keiko Inami, Ryan Holland, Anna Maciag, Zhao Cao, Youseung Kim, Arjun Iyer, Joseph Hrabie, Joseph Saavedra, and Larry Keefer. Nature Protocol (In Progress- 2015)

Research Presentations:

[Oral]… CBL-Drug Design Section /NCI at Frederick, MD (Nov 13, 2013) Diazemiundiolate/Alginate-Based Anticancer/ Microencapsulation Technique.

[Oral]… CBL-Drug Design Section /NCI at Frederick,MD (Oct 10, 2012) “Emergence of the NONOate Capsule” Targeted Delivery of NO via a Diazeniumdiolate/Alginate-Based Nanocapsule System: Nanotechnology and the War against Cancer.

[Oral]…5th Chinese Chapter Conference of the International Hepato Pancreato Biliary Association (IHPBA).Shangri-la Hotel Wuhan in Wuhan, China from(March 23-25, 2012). Future Clinical Impact of (NO and NO2-) on HepatoPancreatoBiliary System.

[Poster]…Pre-ISSOTL: International Perspectives on Engaging Undergraduate Students in Research and Inquiry. Milwaukee, WI. (Oct 19, 2011) The Junior Scientist Training Program

[Oral]…Lab of Comparative Carcinogenesis/NCI at Frederick (July 22, 2009) Translational Research at NCI and The Clinical Benefits of Nitric Oxide Investigations.

References:

1) Tam Cillie

FDA/CDRH/OSB

10903 New Hampshire Avenue WO66 RM2536

Silver Spring MD 20993

301/***-****

email: acyfj0@r.postjobfree.com

2)Lawrence K. Keefer, Ph.D.

Chief, Laboratory of Comparative Carcinogenesis

National Cancer Institute- Frederick, National Institutes of Health

Building 538, Room 205

1050 Boyles Street

Frederick, MD 21702-1201, USA

acyfj0@r.postjobfree.com

3) Richard O. Cannon, M.D.

Director, Clinical Cardiology,

Translational Medicine Branch

National Institutes of Health- NHLBI

10 Center. Dr., Blg 10- CRC 5-3330,

Bethesda, MD 20892 – 1454

acyfj0@r.postjobfree.com

4) Tarmar Murdock, M.D.

Assistant Professor, School of Arts & Sciences

Coppin State University

2500 West North Avenue

Baltimore, Maryland, 21216

acyfj0@r.postjobfree.com

5) Charlotte D. Kaboré, MS, MPH, MCHES

Lieutenant, U.S. Public Health Service Commissioned Corps

Arthritis, Epilepsy, and Well-Being Branch, Division of Population Health

National Center for Chronic Disease Prevention and Health Promotion

U.S. Centers for Disease Control and Prevention

4770 Buford Highway NE, MS F-78

Atlanta, Georgia 30341

(770) ***-****

Email: acyfj0@r.postjobfree.com



Contact this candidate