Training Clinical Research

Ebubechukwu Nnaemeka Onwasigwe, MD

**** ******** ******, **********, **, 29118

Email: ************@*****.***

Tel: 803-***-****

CAREER OBJECTIVE

To obtain a position as Clinical Research Associate (CRA) with a pharmaceutical / biotechnology firm where I can

utilize my medical and clinical research knowledge along with my strong technical and procedural skills in clinical

monitoring to meet the growing needs for clinical trials of new drugs and medical devices in multiple therapeutic

areas. Also, to play my part in reducing the time it takes for a new drug to progress from NID through NDA to the

market while adhering to FDA rules and regulations.

SUMMARY OF QUALIFICATIONS:

In-depth knowledge and experience in clinical research monitoring.

Proficiency in reviewing protocol compliance, focusing on inclusion/exclusion requirements.

Detailed knowledge of ICH, GCP, FDA, TPD regulations.

Maintain associated documentation, record keeping, collection and organization of scientific data.

General clinical care of patients.

Cardiology, Nephrology, Emergency Medicine, Intensive care, Endocrinology, and Gastroenterology,

Pediatrics and Obstetrics & Gynecology, Internal Medicine, Psychiatry, Neurology, & Ophthalmology.

Outstanding leadership, interpersonal, verbal and written communication skills.

Proficiency with Microsoft Office applications - Microsoft Word, Microsoft Excel, PowerPoint.

RELEVANT SKILLS:

Clinical Trials Monitoring

Designed and reviewed CRFs

Verified CRF data with source document and documented errors

Identified potential study sites

Drafted consent forms, randomization list, clinical supplies shipping form, monitoring reports, etc.

Assured adverse events are reported according to regulations and company policy

Review drug accounting, storage, dispensing

Study Planning Activities

Identify potential investigators

Ensure study file is complete and ready for audit

Reporting of adverse events according to regulations and company policy

Visit sites as scheduled/required.

Review protocol compliance, focusing on inclusion/exclusion requirements

Conduct source data verification

Document and file annual IRB approvals

Assure receipt and filing of CVs for investigators/sub-investigators added after study initiation

Monitor site visits reports for any required action

RESEARCH WORK AND CLINICAL EXPERIENCE:

Research on Investigation of resistance training and aerobic exercise on Feb. 2012 - Present

muscle mass, blood lipid profiles and Insulin Resistance in

Ebubechukwu Nnaemeka Onwasigwe, MD Tel: 803-***-****

Elderly Type 2 Diabetics

Results presented:

The 17th Biennial Research Symposium in (Association of the 1890

Research) from April 7th -10th, 2013.

The research at the 70th and 71st Professional Agricultural Workers

Conference (PAWC), December 2nd -4th 2012 and December 7th -9th

2013 in Tuskegee, Alabama.

The 17th Biennial Research Symposium in (Association of the 1890

Research) Jacksonville Florida from April 7th -10th, 2013.

College of Health Sciences, University of Debrecen, Hungary March- April 2011

Research in Ophthalmology

Thesis research was on Fluorescence Angiography in Intraocular Tumors

and various Procedures leading to its Diagnosis and Treatment

May 2010 – April 2011

University of Debrecen Teaching Hospital, Hungary

Internship - Psychiatry, Neurology, & Ophthalmology

Feb 2010 – March 2010

Semmelweis Hospital Budapest, Hungary

Internship - Surgery and Internal Medicine

Oct 2010 – Nov 2010

Heath Hospital, Cardiff, Wales, United Kingdom

Internship - Pediatrics and Obstetrics & Gynecology

EDUCATION AND CLINICAL RESEARCH TRAINING:

The CRA Training Institute, 2014 Houston Texas USA

CRA Professional Development Certificate Program

ICH GCP Training

Clinical Site Monitoring (site selection, initiation, monitoring and close out)

Adverse Event Reporting

Pharmacology for Clinical Research Professionals

South Carolina State University, SC

Masters in Nutritional Science – 2014

College of Health Sciences, University of Debrecen, Hungary

Doctor of Medicine (M.D) - 2011

Computer Skills - Microsoft Word, Microsoft Excel, PowerPoint, Adobe Acrobat, Internet Skills

Languages:

English Language: Fluent, written and conversational

Ibo: Fluent, written and conversational

Hungarian Language: Basic, written and conversational

References: Available upon request

Ebubechukwu Nnaemeka Onwasigwe, MD Tel: 803-***-****

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