Clinical Data

PETER CHUK OBIARINZE

**** ***** ***** #***

COLUMBIA, MD 21045

Home # *** - *** - ****

Mobile # 443 - 537- 0231

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AREAS OF EXPERTISE:

Clinical trials phase/Investigative Clinical Research Data management

Clinical Therapeutics data Analyzer and clinical investigation /Data management

Regulatory affairs protocols SOP and GCP good clinical practice compliance

Elisa immunoassay control and analyses

Therapeutics clinical trials monitor / Human subject Policy matter

Oncology and Cancer research trials,

Allergy Disease, Asthma & Bronchitis trials

Cardiology and clinical Heart Disease study trials

Stem cell research & cell regeneration infusion

ZIKA virus vaccine clinical trials, Stage 2

PROFESSIONAL EXPERIENCE:

Presently on Leave of absent for Board Certification exam

Providence Health, (Better Health Research). Washington DC. Clinical Research Trials Specialist,

(Site monitor validation & Compliance, including regulatory visits duty) May 2007. –Dec 2017

Gathering of source resources information from clinical Investigative documentation to facilitate scientific values and qualitative sources guided by the IRB guidelines to ensure ethical safety and regulatory requirement while maintaining institutional compliance with federal and state regulatory protocols for FDA final review and approval. Including ICH which is the international code of harmonization

Assigned to perform clinical investigative research and in charge as a clinical foreman to ensure strict GCP, by applying the ethical guidelines and regulations of state and federal CFR using the Belmont report and the accepted declaration of Helsinki in addition to the doctrines and rules of CIOMS which is the council for international organization of medical science.

Involve in the monitoring and regulatory research and ethics doctrine, applying good clinical practice GCP and good management practice GMP in the administrative appeal process for site startup in addition to applying a regulatory program for human research ethics and oversight.

Collaborated with the clinical research group to document and monitor the clinical study of assigned sites to assure the adherence to protocols in CTT clinical trial test to ensure GCP, and FDA ethics and regulations to achieve the intended clinical objectives in the clinical study.

Conduct a though prequalification selection from start up initiation procedure to the clinical investigative coordination of the interim activities and the close out visits of the clinical trials program.

Provide regulatory based written reviews of protocols using standardized checklist.

Formulate and recommend potential solutions to complex problems that would help bring the protocols in compliance with the various ethical laws, and regulation, including policies, and procedures in addition to guidelines governing the human subjects research including regulatory coordination, e.g. ( work with other regulatory offices to coordinate human subject protection reviews) as required

Constantly hold investigative meeting with research colleagues to discuss and apply new intentions and review under the IRB.

Provide regulatory based written review and action following a R202 required format using standardized checklist. This may include, but not limited to review of amendment/ addendum. Continuing the review report, report of unanticipated problems and serious adverse event, report of serious or continuing non compliance report of research, that may include suspension / termination, protocol deviation, subject complaint and final study report, in addition to providing a professional quality written review.

Support the CRO and the government in conducting a review of assurance request and site visit including a review of standard operating procedures SOP and the institutional review board IRB

Complete project activities associated with monitoring functions clinical phrase 1 to 4 while developing the mastery and a thorough understanding of the drug development process.

Provide consultation assistant, support with planning of procedures and assessment of site monitoring for human relation ethics

Actively involved in the update of document and information flow system that is related to protocol that involve qualitative report and quantitative review of QC and other lab report

Responsible for providing timely and accurate visit report and develop an oversight in human subject protection policies including protection guidelines and the necessary template such as informed consent form checklist to ensure a complete compliance of regulatory law and ethics standard.

Responsible for performing on site visit or remote site management activities for assigned investigative site.

Responsible for managing clinical and regulatory aspects of assigned sites to ensure compliance with protocol specifications, SOPs applicable regulations and guidelines

Responsible for ensuring the integrity of the data collected when source data verification is performed

Responsible for participating in sponsor and regulatory site audits and inspections including preparation, attendance and follow up finding

Responsible for providing ongoing support to investigative site to facilitate the conduct of the study.

Responsible for the observance of ethics and regulatory submissions activities including consulting, submission, and projected feasibility.

Responsibility also includes, to be seen as an advocate for trial sponsors and subjects, acting as liaison between trial sponsors and the CRO. Provide risk assessment and advice recommendation to all sources in the appropriate form of data record, and management.

Serve as monitor for CRO sponsored clinical trials, evaluate, and assure accuracy, consistency, and attention to details tracking activities of clinical sites and records.

Responsible for startup design and the actions on strategies of approved trial system and the practice in clinical trial site, which includes a strict observance to ICH, this is the code of harmonization.

Responsible for providing scientific oversight, in addition to monitoring the CTQA, which is known as the clinical trials quality assurance from the data base and work to prevent violation of regulatory and ethical standard of CFR in human subject protection issues in client sponsored clinical trials.

Responsibility includes data management, which includes case report form, CRF and informed consent form, ICF. Supporting title 21 and the code of federal regulation CFR.

Duty assigned are of Compliance review, site follow up inspection, documentation and regulatory inspection review, including electronic information data transfer, in addition to study subject screening, patient recruiting and review of (informed consent form) for CFR and title 21 i.e. code of federal regulation and human subject policy matter.

Assigned to ensure that trial report are Proper Documentation into the trial master file with supporting clinical evaluation which is referred to as CE, including a supporting evidence and prognosis for the acceptance inclusion known as ITT, which is referred to intention to treat.

To comply with the code of federal regulation CFR and human subject policy matter, a study file is opened called activity of daily log. Which is referred to as ADL, in addition, all intentions and purpose are grouped under IC which is referred to the intended intention cure, including the Q&A laboratory report supporting the criteria for test of cure.

The unknown investigational new drug used in the trials are referred to as IND during the period of TOC is referred to as test of cure, and the EOT is referred to as end of test, which is close out trials.

Responsible for data collection and review, also assigned to monitor and observe the ethical procedure and compliance in accordance to federal and state rules and regulation that is related to the clinical trials study within the institution. In addition to attention to details on the Q&A lab report with the medical staffs of physicians and physician assistant including duty nurses.

Frequently hold coordinator investigative meetings for trials review, new protocols and progress on test of cure, which is TOC and end of test close out, which is EOT on the IND (investigational new drug).

Represented or seen as advocate for patient or client. Review case report and properly complete case report form following the SOP procedures and informed consent form. Performed client overview.

Monitor the progress report sheet on trial candidates and constantly holding investigative meeting with chief investigator during the test of cure trial and a final report on the close out.

Clinical trial coordinator July 2006- May 2007

This is an attention to details to details assignment. Which include support, facilitates and coordinate the daily clinical trials activities and play a critical role in all aspect of the clinical conduct of the study and guide line. Assignment includes working with the principal investigator, the oversight group, sponsor and the clinical host sight to conduct all the aspect of the clinical trials according to the protocol, FDA regulation, ICH/GCP guidelines including the IRB policies and other governing authorities.

Coordinated all the activity of the site monitoring from study start up to close out.

Frequently hold coordinator and investigative meetings for review of new protocols and discovery on TOC test of cure and EOT end cure trials on IND, investigational new drug.

Ensured that all documented forms are in enough supply, that all the right forms are used and well documented, made sure that process are well explained to patient and clients on trials, following the informed consent form.

Obtain medical records and history as related to the clinical trials

Complete subject visit per protocol and record all information gathered in source document

Communicate constantly with principal investigator and sponsors regarding laboratory data discovery and discrepancy

Recognize common laboratory values and alert and instigate all appropriate action required

Adherence to the strategy of inclusion and exclusion policy on enrollment

Develop and maintain knowledge of protocol on the related medications and illness

Represented as a true advocate to the company from client, in supporting clinical trial as source resources information.

Review clinical data in details from all sources in data and assuring that a procedure GCP protocols by IRB is in compliance.

Conducted a complete review which includes a proper and detail explanation of client ICF which is the informed consent form and risk involved.

Analyzed and review laboratory report from start to avoid interaction and that clients in trial program must fall within parameter and the criteria stipulated.

Must ensure those clients qualify and falls within the parameters of inclusion and exclusion.

Involved in the period and daily review of patent study binder or sometimes called daily activity log and all source documents, data collection, data entry and liaison communication with the sponsor and CRO.

Must ensure and documented that all the applicable SOP and institutional policy and ethical principles are applied.

Assist the investigator PI with the preparation of regulatory submission to IRB regarding base line procedure the process of the TOC test of cure and the final EOT which is the end of test close out.

Must be in constant touch with information flow with the sponsors of program trial and the chief investigator.

Must ensure that the selection for trials fall between the parameters of inclusion and exclusion, so as to fall between the federal guidelines of acceptance into the trial program.

Coordinate the patents ethics guidelines are properly followed while using the standard SOP which is the standard operational procedure and the implied ICH since international country have code of conduct.

Monitor and coordinate the ethics and acceptable parameters for trials clients are followed.

Coordinate the source resource data collection and source documentation through the electronic data capture.

Monitor and ensure that the site forms are in enough supply, e.g. like the daily progress sheet report form and case report forms for AR and SAR are in stock.

In charge of the daily monitoring of projects and activity for the site, including forms and auditing. Inspect and oversaw site condition including all the daily activity to ensure that country law, including the federal rules, ethics and protocol followed, upheld and documented.

Assure a proper storage of site documentation and medical investigational therapeutic and hand out drugs, dispensation of material and assures accountability of all investigational product and trial related material.

Must be in constant look out for any violation and all AR and SAR are quickly reported to the PI and sponsors of trials.

Clinical Data Management June 2006 – July 2006

Assigned to document all activities into the electronic data system in correspondence to the daily case report form or the daily activity report log.

Documented all critical info in the electronic documentation or filed in patient study binder on all activity and action taking, which includes.

Performed source data verification according to contractual requirement interpretation included in the protocol after the signing non-limited liability consent forms.

Recorded all observances in the trial master file enrollment, including all the files that are opened documented activity during the test of cure trials process TOC to the end of cure trial close out EOC.

Performed and explain the required inclusion criteria and exclusion criteria.

Involved in the periodic and daily review of client file or client study binder.

Review and screening of clinical master files and regulatory document.

Involved in the review of protocol amendment, and IRB review.

Document and apply all applicable SOP, institutional policy and ethical principles governing the human subjects.

Document and review all protocol before submission to IRB approval.

Assist investigators and coordinators with the preparation of regulatory submission to IRB regarding baseline procedure through TOC, test of cure and the final EOT end of test.

Maintain research regulatory database of master file including the case narrative development to data review committee.

Osiris Therapeutics, Baltimore, MD April 2005 - Oct 2005

Stem Cell Research Trial Coordinator

Purpose of research is to find a cure for the regeneration treatment and cure for damaged necrotic tissue and damaged chondrogene using adult stem cell through a process of mesenchymal cell and prochymal cell for repairs of necrotic tissue, thereby promoting tissue regeneration and functional restoration of damaged or diseased tissue. This is a stage 2 phase trial.

Review the procedure and documentation for the clinical trials grown cells in the lab using the java cell count technology for accuracy for quantizing stem cell and chondrogene regeneration and repair.

Prepared and review the master file and SOP documentation for trials for tumor necrosis factor receptor TNFR typ1 in human for mesenchymal stem cell research.

Prepared and review report on procedures on steps and all the cache involved in calculation on purpose, procedure, result on lab log for references and comparison.

Most laboratory discovery is by planning attention to details reactive data, with a rare en vivo accident and unintended reaction polystyrene micro plate and lyophilized cells of human TNFR are carefully analyzed in plate reader micro count on ppm according to settings on controlled standards.

STUDY LEAVE OF ABSENT FOR MEDICAL BOARD EXAM CERTIFICATION

JAN 2005 – APRIL 2005

Walter Reed Institute of Army Research, Rockville, MD

Contract under on assignment Lab support Inc. Nov 2003 – Jan 2005

HIV Diagnosis Assay Laboratory Research, (Retro virology).

Performed the review of assay process and inspection of HIV samples for the detection of HIV using FDA EIA approved method on the biorad Evolis machine.

Secretly handles and clinically perform HIV test on research on Thailand, Germany, Kenya and Korea samples sharing statistical info via network on ABTS military HIV research and viral overload, this information is kept in a study network to track the progress in the research data base.

Performed the review of procedure used prepared diluents and reagents for the conjugates and the chromogene for the trials test. Performed a complete screening of retro virology attachment on different recombinant cell.

Conducted and ran clinical and research samples from all US military basis overseas on HIV and hepatitis using the sensitive EIA test on samples provided.

Reported into the CHCS military network adjusted the MOD, MWD, UWL, and LST. For statistical report on controls and tracking on HIV endemic and pandemic and the reaction of applied titers on HIV.

Performed Hepatitis B check and titers check on blood and serum samples that tested positive for hepatitis.

Performed a recheck on HIV positive serum samples that tested positive on Evolis biorad system using the western blot assay method, insure effective documentation of all method is documented, in order to chart a new medication for patient as an investigational new drug.

Assist in the delivery of biohazards HIV samples at drop off location for proper destruction

Med-Immune Inc. Pharmaceutical, Gaithersburg, MD June 2003-September 2003

Molecular Microbiology Cancer Research Assistant

Performed assay on cancer cells using different antibody test and cell line e.g. focus cell, Nec cell, SMCF7 cells, and tumor causing cells for reactions and hyper reactions to check competency, in addition to proliferation check on micro granular apps called (cintillator).

Inject lab mice with antibody for cancer and tumor growth measurement called cytometry measurement for a continual observation and follow up.

Dissecting and removing spleens from mice for preparations for LDH release ADCC assay on effectors cells adapted to VITAXIN vaccine as in phase 2 trials.

CYTOGAM, phase 2 trials is intravenous human immune globulin for cytomegalovirus associated with transplantation of kidney, lungs, heart, liver and pancreases.

Prepare target cells for ADCC and for antibody reaction comparation if test with effector cells and target cells are working as planned on clinical trial investigational name called ethyol vaccine as in phase trial.

Performed efficacy test anti HAAH mAB, 15C7, 1A7, P33CA, monoclonal antibody on cell lines that binds to tumor antibody, etc.

Performed the chemical procedure called lyopholisation to preserved good acceptable samples that will be worked on a later date for vaccine development and air dried to a fluffy stage for DNA preservation and use.

Performed quantitative Elisa protocol on immune globulins M reaction on different class of supernatants as designated on substrate, medium and AB using standard curve for final competency in analyzing graph.

Transferred to Fredrick Vaccine Production Division and Site

Performed the duty of inspecting the high pressured tanks for production of vaccine attenuation culture silos, assigned to inspect, uphold standards and ensure for top regulatory standard SOP and inspections and sanitization of all systems checking for ppm count on air force particles and regulatory for vaccine infusion, checked for afflotoxins and bacteria in sterilized water used for vaccine and the lyophilized culture growth development.

Trials Success: ACHIEVEMENT

FLUMIST approved intranasal Flu vaccine against influenza virus.

MOTAP anti cancer neuralgia clinical trials.

SYNAGIS. Approved for serious lower respiratory tract disease.

EHYOL is used as a cellular protector /organ protector against radioactive and proton toxicities on the body and organ with chemotherapy and radiotherapy for Cancer patients. Today aka UNPOGEN NEULASTA, immune booster for IV ringers.

GARDISIL Vaccine. For HPV human papiloma virus immune viral prevention.

ANTEX Biologics (Antex Pharma DIVISION), Gaithersburg, MD

Nov 2000 – Sept 2002

Research Associate ANTHRAX VIRUS

Performed protein assays for immune count for vaccine, immunology Elisa, gel and protein synthesis expression on gel acryl amide and cell paste preparation. Baculo procedure, Campylobacter Jejunum, helicobacter pylori S-sonnei, etc.

Performed microbe susceptibility test on bacteria cloned DNA microbe reaction.

Performed purification, midi-prep, and western and serum protein expression.

Prepare vaccine for injection for trial cure on infectious diseases, making whole cell protein expression and for vaccine trials.

Collect samples for sonicator blending.

Performed lyophilisation of samples to be preserved and stored on vials for future and later needs.

Perform western block and gel acryl amide staining for DNA marker on thin strip.

Performed Elisa and virus and bacteria immunoassay.

Life Technology (Invitrogen), Fredrick, MD April 2001- September 2001

Research Associate

Prepared assay plate for research labs DNA sequencing and molecular biology.

Prepared the DNA test plates, including the gel electrophoresis and synthesis purification by phosphor-amidites chemical reactivity for genetic marker DNA sequencing.

Apply the use of HPLC, synthesizing multi-spec, and cathode and capillary electrophoresis.

Prepare reagents stock, for sequencing in accordance to chemical MSDS and regulatory affairs, synthesis of oligo-nucleotide.

Prepare ordered plates for DNA research and matching, forensic analysis and paternity.

DIGENE Diagnostics, Gaithersburg, MD January 2001-March 2001

Research Associate (HPV & Hepatitis Vaccine)

Performed Assay and Elisa on plasma and serum for drug control test on infectious diseases, hepatitis virus, HIV control drugs, Papilloma, condyloma and CMV. Allergy ophthalmology cream and solution.

Performed control trials by adding plasmid to sample, DNA sample, Herring sperm, EDTA and chemical indicator reagent called azide to serum for research base line control specification on pharmaceutical ophthalmologic solutions.

Performed assay on plate multi-wells, adding reagents, serum, probe and de-naturation mixed reagent, DNA sequencing.

Conducted DNA & Hybrid separation on capture plate transfer and the isolation of hybrid for count /Performed protein filtration.

TODAY SUCCESS 1.gardisil vaccine.

EDUCATION

MD. Medicine. September 2000, University Central Del Este, Dominican Republic

BS Biological Sciences, May 1985 Langston University, Langston, Oklahoma

SUPPORT TRAINING

NIH Clinical Trial Investigator Training

Clinical Lab investigator Training

PROFESSIONAL AFFILIATIONS

Clinlab Registered member for clinical Research investigator (Purdue University accepted accreditation)

PUBLIC RELATIONS:

LANGUAGES: English, Spanish, Italian, Arabic

SKILLS

Current trials Investigation,

H1N1 Virus, TOC phase 2 and 3

New base line trials,

Multiple Sclerosis (MS) Trials on Fingolimod and Cladribine,

Zika Virus Vaccine trials Phase 1,and phase 2

India 1 superbug

Colistin mediation clinical trial

Trials Achievements:

Tegacycline antibiotic ES.

Desgrene ticlopidine anti Platelet.

Statin cholesterol effect decloster.

Dermovate for topical triamcelone.

Clobetasol, topical Cre Taro.

Vitaxin intraveinous anti cancer cell ankylosante

Abiraterone for prostate cancer (very promising).

Docetaxel for cancer chemotherapy and all neoplasia

Tamsulocil Prostate medication.

Refuximab duo cyclophosphamide

Carmustine for anti neoplasia for cancer research trials.

Cyterabine for leukemia research trials.

Gillead for non hodgkin lymphoma, including marginal criteria on Yescarta and Kymriah

Afinitor (evarolimus) for breast cancer, kidney, tumor.

Doxil, for breast cancer and ovarian cancer trials / influence on Kaposis sarcoma.

Sandostatin for pancreatic tumor, islet cell tumor, and gastrinoma research trials.

5 FU (flouro-uracil ) for colon cancer research trials.

Colistin and plasmid mediation trials.

SURGICAL EXPERIENCE

Radiofrequency ablacion and Vetebra kaphoplasty procedures

NATIONALITY:

US CITIZEN

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