Summary

Clinical Trials

• Extensive experience in conducting pre - clinical testing with chemotherapeutic drugs on cell lines.
• Hands on experience with phase I of clinical trials using chemotherapeutic and anti-inflammatory drugs.
• Responsible for the implementation and execution of protocols and project plans as assigned.
• Interacted with patients participating in phase I regarding the Informed Consent forms and monitoring the dosage administration effects.
• Proficient with MS Excel, Access and IMPACT CTMS for managing the obtained trial data.
• Experience with Phase II of the clinical trials through rotations on-site using the demonstrated results from Phase I.
• Familiar with Phase III of the clinical trials through rotations and observations.
• Extensive experience reviewing IRB submissions and complying with the IRB approvals.
• Tracking, reporting and recording ADRs (Adverse Drug Reaction) by completing the CIOMS form.
• Proficient with 21 CFRs as mandated by the FDA for the clinical trials.
• Completion of regulatory documents such as 1572 FDA documents and Investigator statements.
• Completions of CRFs (Case Report forms) according to CRF completion guidelines of the FDA.
• Reporting AE (adverse events) and SAE (severe adverse events).
• Written and improvised SOPs (Standard Operating Protocols), ensured compliance with GCP.
• Trained extensively in OSHA regulations as described in the 29 CFR 1910.10130 and mandated by the FDA.
• Maintaining confidential patient information according to HIPPA using MS Access in order to comply with 21 CFR part 50.
• Responsible for reporting the outcome of the trial according to the CONSORT guidelines and maintaining confidentiality of the reports obtained.

Clinical Research

• Profiled the expression of TLR (toll like receptors) on GI cells obtained from patients suffering fromCrohn's disease.
• Expert in Immunohistochemistry (IHC) and Immunocytochemistry (ICC).
• Hands on experience with tissue culture; Feeding, harvesting, freezing and thawing the cell lines.
• Created successful presentations for conferences and presented the obtained accurate data using MS PowerPoint.

Marketing and Sales

• Marketing and distribution of drugs, products, instruments for health care companies like Pfizer and Invitrogen.
• Budgeting/maintaining sales records by interacting with professionals and end users.

Computer Skills

• IMPACT - Clinical Trial Management System (CTMS)
• Microsoft Office (Word, Excel, PowerPoint)
• Microsoft Access
• Microsoft Outlook

Work Experience

Confidential, Somerset, NJ Clinical Research Associate/Clinical Research Scientist

• Administering chemotherapeutic drugs to the cancer cell lines (Caco2), adult stem cell lines and monitoring their reactionin vitro.
• Hands on involvement in the Phase I of the clinical trials approved through the pre-clinical studies on chemotherapeutic drugs.
• Interacting with the 30 human subjects involved in the phase I of the clinical trials regarding the "Informed Consent Form".
• Monitoring the method and concentrations of the dosage of the drug administered to the human subject.
• Observing, tracking and reporting ADRs (Adverse Drug Reactions) by completing the CIOMS form.
• Involved in Phase II of clinical trials through the rotations on-site through rotations using the demonstrated results from Phase I.
• Written and improvised SOPs (Standard Operating Protocols), ensured compliance with GCP.
• Responsible for the implementation and execution of protocols and project plans as assigned.
• Reporting SAE and AE by completing SAE and AE forms.
• Familiar with Phase III of the clinical trials through rotations and observations.
• Reviewing IRB submissions and approval; Completion theof Case report forms in accordance with the CRF completion guidelines.
• Trials and experiment data entry, analysis and presentation usingMS Excel, Access and PowerPoint; Reviewing IRB submissions and approval.
• Trained extensively in OSHA regulations as described in the 29 CFR 1910.10130 and mandated by the FDA.
• Verifying the data obtained, complying with 21 CFR Part 11, ensuring their accuracy, strict adherence to the SOPs and ICH guidelines.
• Responsible for reporting the outcome of the trial according to the CONSORT guidelines and maintaining confidentiality of the reports obtained.
• Profiling the expression of TLR on GI cells obtained from patients suffering from Crohn's disease.
• Expert in Immunohistochemistry (IHC) and Immunocytochemistry (ICC).
• Utilizing Access and IMPACT CTMS to track patient records for ADRs and related genetic factors.
• Ensuring compliance of the research, trials with 21 CFRs as mandated by the FDA and following GCP in the lab.

Confidential, Amherst, NY Pharmaceutical Representative

• Marketing and distribution of drugs, products, instruments on behalf of Schwartz Group for health care companies like Pfizer and Invitrogen.
• Budgeting/maintaining sales records by interacting with professionals and end users.
• Identifying the competitors and analyzing the factors that resulted in the decreased sales of the product.
• Achieved a 4% increase in pharmaceutical sales due to the effective measures taken in the promotion of Medicare part B coverage.

Confidential. Buffalo, NY Marketing Coordinator

• Promotion and organization of the health programs/events.
• Coordinated television/radio advertising, graphic arts and newspapers.
• Modified the divisional information required for submission to the SBI's Marketing & Public Relations Director for the inclusion in the Health Education newsletters and newspapers.
• Achieved an 18% increase in enrollment in the health programs with effective marketing strategies.

Confidential, Amherst, NY Public Relations Specialist

• Interacted and negotiated with reluctant alumni to raise funds for the various departments of the University at Buffalo.
• Entering data and verification of the required data.
• Raised more than $22,000 for the various departments of UB including the School of Dental Medicine, School of Medicine and Biomedical Sciences and School of Public Health and Health Professions.

Confidential, Buffalo, NY December 2007 Intern and Volunteer

• Interned at the lab of Dr. Galwin and volunteered at the hospital.
• Tested samples of DNA and Lysozyme using Coumassie blue and Bromophenol.
• Used PCR and Gel Electrophoresis to perform the experiments.

Education Bachelor of Science, Biological Sciences/Biochemistry

Language Skills Fluent in English and Spanish