Clinical Research Project Management

OGWUCHE JOSEPH IDOKO

***c Overlook Court

Woodbridge, NJ 07095

732-***-**** ******@*****.***

PROFILE

I have strong problem solving skills, excellent organizational skills with an attention to details, motivated self-starter with the ability to think strategically and work independently. I have strong interpersonal and communication skill, with the ability to independently plan and complete projects in a timely manner. Organized analytical hands on team player with a willingness to get involve at all levels.

Areas of strength include:

*Employee development & training *Program and project management *Schedule/ coordination *Team building/ moral building *Problem analysis & resolution *Executive support.

EDUCATION

Advanced Clinical Research, Sollers Institute Edison New Jersey 2016

Paddington College London, England BS in Science Technology 1985

Clinical Hyperbaric Medicine, Westchester Medical Center, New York (CHT) 2010

Kriger Research Center, Inc. Canada DCRA in Clinical Research 2008

Maimonides Medical Center, New York CPR & AED Technology 2007

National Healthcare Association (CPT, CET, CCMA, CMLA) 2004

PROFESSIONAL EXPERIENCE

Internship Programs:

Advanced Clinical Research, Sollers Institute Edison NJ 2016.

This is to develop and train Students to understand and navigate an array of regulations and policies that pertain to conducting, monitoring and managing clinical trials.

It also covers the entire scope of Clinical Data Management system from processes and standards to tools used.

Conduct, record and monitor patients’ blood glucose using glucometer

Care and treatment of patients’ wounds

Monitor and supervise the transportation of patients’ to and from the Center

Clinwell CRA, Kriger Research Center, Inc. 2004-2008

Clinical Research Projects Completion in the following areas:

Application ICH and GCP guidelines

Development of study timelines including IRB approval and bulk drug manufacturing

Review protocol requirements, sponsor policy on CRF and inclusion/exclusion criteria Evaluation and finalization of study budget for a clinical site

Conduct clinical site selection visits, site initiation visit, and study closeout visit

Use of SAS programs to access, manage, analyze, and present data

Conduct routine monitoring visits to ensure investigator and staff are in compliance with protocols, TDP, FDA, and ICH regulations, GCPs and pertinent SOPs

CORE COMPETENCIES:

Clinical Trial Experience Working with CRO’s Conducting /Supporting Oncology Trials hase 1 to Phase 4

Good knowledge of complete aspects of the Clinical Trials Operation and Protocols

Complete knowledge of GCP, ICH, FDA guidelines including understanding of regulatory requirements

Demonstrated experience in Drug Development, Drug discovery and Approval Process

In-depth experience in Product management, inventory, labeling, storage, shipping, product line profitability, creating product line strategy, new product introduction, pricing and analysis, defining and managing market research

Broad experience of Medicinal chemistry in Antiviral, Antitumor and Anti-Inflammatory areas with good knowledge of Pharmacology, Epidemiology and Toxicology

Experience in managing CRO teams in China, England and India

Technical and nontechnical writing

Familiar with Clinical Trial Management System (CTMS), Clinical Data Management Practice, Clinical Project Management

Clinical Data Management tools: Oracle Clinical (CRF, DVG, DCM, DCI, Global Library, Data Extract, procedures, Data Entry, Mass Update, Batch Data Load), SAS (BASE, SAS/ SQL, SAS/ MACROS)

Hyperbaric & Wound Care Technologist, East Orange General Hospital, East Orange, New Jersey 2004-2010

Assist the multidisciplinary Physician group with years of Diabetic and Wound Care experience operate the Hyperbaric and Wound Care Center

Facilitate patients’ physical examination by recording and monitoring vital signs

Senior Research Laboratory Technologist, Department of Pharmaceutics, School of Pharmacy, University of London, England 1980-1985

Organized and supervised Laboratory experiments for undergraduate and graduate students

Executed the maintenance and troubleshooting of high tech laboratory instruments and equipment such as microscopes, spectrophotometers, colorimeters, PH meters, centrifuges, microtones and balances

Superintendent Technologist, Department of Biological Sciences, Ahmadu Bello University, Zaria, Nigeria 1980

Trained staff and students in various scientific experiments such as media preparation, cell culture, histology and chromatography techniques,

Conducted the preparation and application of laboratory chemicals and reagents in biological sciences experiments

Compiled and evaluated research reports on various scientific experiments such as cytogenesis, genetic control and development, and protein structure and analysis

PROFESSIONAL LICENCE AND CERTIFICATIONS

Certified Hyperbaric Technologist (CHT)

Certified Clinical Research Associate (DCRA)

Certified CPR & AED Technology

Certified Phlebotomy Technician (CPT)

Certified EKG/ECG Technician (CET)

Certified Clinical Medical Assistance (CCMA)

Certified Clinical Medical Laboratory Assistant (CMLA)

COMPUTER SKILLS

Software: Microsoft Outlook, Microsoft Excel, Microsoft Access, Microsoft Word, Power Point

Hardware: Maintain and troubleshoot high tech laboratory instruments and equipment

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