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Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 xxx-xxx-xxxx ● abc@xyz.com

Highly experienced Scientist seeking opportunity as a Clinical Research Associate.

Biomedical Research ~ Regulatory Compliance ~ Clinical Trials Data Coordination

Health Services Administration ~ Collaboration ~ Reporting ~ Study Protocols ~ QA ~ Safety

 

Profile

 

         Offer 15+ years research experience and advanced knowledge of statutory regulations, International Committee for Harmonization (ICH)/Good Clinical Practice Guidelines (GCP), FDA requirements, and Institutional Review Board (IRB) and Animal Care Committee and Clinical Trials monitoring principles.

         Extremely well-versed in biomedical research, statistics, strategic planning, clinical data management, and drug safety.

  • Possess sharp organizational, training, supervisory, technical, public speaking, and analytical skills.

         Able to leverage proficiency in medical terminology and clinical research process to clearly communicate highly technical reports to key stakeholders and decision-makers.

         Strong understanding of health care policy analysis and application in clinical trials and for cross-disciplinary application in pre-clinical drug discovery studies, clinical studies, and data management including risk-based monitoring.

         Outstanding talents in bioinformatics analysis, molecular biology research platforms, and health policy research.

         Skilled at managing clinical and scientific documentation and steering consistent regulatory compliance.

         Provided critical data to senior leaders within US Department of Health for developing initiatives and policies on various portfolios including transplantation.

         Adept at reporting adverse events, tracking clinical trial status, preparing progress reports, and conducting proper trial close-out procedures.

 

Professional Experience

 

Spelman College, Atlanta, GA 2009 to 2015

Assistant Professor / Principal Investigator

         Spearheaded biomedical and pre-clinical studies, successfully acquiring multiple research grants and 10+ peer-reviewed publications in scientific journals.

         Devised and delivered innovative curriculum in Genetics, Cell and Food Toxicology, Molecular Biology and Genomics to double student enrollment and result in successful placements in graduate programs and research facilities.

         Exhibited dynamic resourcefulness in genetically engineering panel of recombinant cells used in functional genomics profiling and cell-based bioassays used in drug discovery investigation.

         Presented research findings at numerous local and national conferences.

         Prepared comprehensive IRB applications and Informed Consent documents for research projects.

         Served as primary reviewer of investigators applications and actively contributed to IRB/IACUC committee members deliberations for regulatory compliance and approval.

 

Morgan State University, Baltimore, MD 2006 to 2008

Associate Professor / Director of Environmental Toxicology Core Facility

         Revamped curriculum within Genetics, Molecular Biology, Environmental Toxicology and Environmental Carcinogenesis programs to increase student enrolment by 50%.

         Supervised technical staff and research students within facility, and maintained biomedical research equipment.

         Upgraded HPLC systems and assembled user manual which doubled use of facility by principal investigators and research students.

 

Continued ►

 

 

Professional Experience continued Yyyyyy x. yyyyyy Page 2 of 2

 

Georgia Institute of Technology - IBB, Atlanta, GA 2001 to 2006

Research Scientist

         Performed broad-scope research tasks including engineering human DNA and constructing recombinant cells for metabolic profile, pharmacokinetic distribution, immuno-chemical analysis and confocal microscopy.

         Strategically expanded analytical platform from biochemical to toxicological cell-based functional imaging bio-assay.

         Advised, mentored, and provided influential technical support and guidance to graduate student.

 

National Center for Toxicological Research (NCTR), AR 1992 to 2000

Guest Scientist

         Orchestrated research project in Genetic Toxicology and Pharmacogenetics with scientific staff at Federal Research Center.

         Engaged, inspired, and mentored students in biomedical research, increasing their evolution into a biomedical research career path by 75%+.

         Instituted multi-agency student internship program featuring partnership between NCTR, University of Arkansas at Pine Bluff, and Department of Health and Human Services.

         Awarded NIH-funded grants as Principal Investigator and Co-Principal Investigator on several projects.

 

Office of Science Policy, US DHHS, Washington, DC 1997 to 1998

Health Policy Analyst

         Provided critical background information used to formulate health policies related to children s environmental health risks, bioterrorism, and xenotransplantation.

         Launched internship program to foster collaboration among federal and state government agencies and university.

 

Arkansas Cancer Research Center, Little Rock, AR 1996 to 1997

Administrative Intern

         Supported study staff in managing bone marrow transplantation clinical research data for Investigational New Drug (IND) application.

         Promoted and supported cohesive cooperation among key clinical study opinion leaders including investigators, administrators, and providers.

 

Education

 

Master of Health Services Administration, University of Arkansas, Little Rock, Arkansas

 

Ph.D., Cell Biology, Atlanta University, Atlanta, Georgia

 

Bachelor of Science, Biology, magna cum laude, Benedict College, Columbia, South Carolina

 

Certifications / Professional Development

 

CRA Professional Development Program, The Clinical Research Training Institute, 2016

(Key areas of study: ICH GCP; Adverse Event Reporting; Pharmacology for Clinical Research Professionals;

Informed Consent forms and Documents Construction; Site Monitoring for Clinical Research Professionals)

 

Collaborative Institutional Training Initiative (CITI) Certifications:

Biomedical Responsible Conduct of Research; Good Clinical Practice Course; Human Gene Transfer Trials;

IACUC Chairs, Members and Coordinators; IRB Members

 

Software

 

Microsoft Office (Word, Excel, PowerPoint), clinical trial systems, SPSS, SQL, gene annotation & bioinformatics software

Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 xxx-xxx-xxxx ● abc@xyz.com

 

 

 

Addendum

 

 

 

Key Publications & Presentations:

 

 

Yerokun, T. and Winfield, L. Celecoxib and LLW-3-6 Reduce Survival of the LN18 Human Glioma Brain Tumor Cell Line Independently and Synergism with Sulfasalazine. Journal of Cancer Therapy, 35, 6419-6424. http://www.ncbi.nlm.nih.gov/pubmed/26637851, 2015.

 

Yerokun, T. Neblett, T. and Johnson, C. Molecular Profile of Human Serine Palmitoyltransferase-1Proximate of Chromosome 9 Disease Susceptibility Gene Cluster in Inflammatory Cancer Cell Lines. Journal of Cancer Therapy, 5, 885-901. http://dx.doi.org/10.4236/jct.0000 xxxxxx xxxx , xxxx , xxxxx 000006, 2014.

 

Yerokun, T. and Stewart, J. Novel functional association of SPTLC1 A peptide in sphingolipid metabolism with cytochrome P4501A1 transactivation and proliferative capacity of the human Glioma LN18 brain tumor cell line. Int J Environ Res Public Health, 3:252-261. http://www.ncbi.nlm.nih.gov/pubmed/16968971, 2006.

 

Effect of microRNA-137 Mimic and Inhibitor on Expression of Human SPTLC1 in Inflammation Associated Cancer Cells Exposed to Heat Shock. Emory University, 2015.

 

Modulatory Effect of SPTLC1 Expression on Genotoxic Response of Cultured Cells. RCMI Symposium, Morgan State University, 2007.

 

Involvement of Serine Palmitoyltransferase-1 in Genotoxic Stress Response. Twelfth International RCMI Symposium, Puerto Rico, 2006.

 

Confocal Imaging of Serine Palmitoyltransferase Localization in Genotoxic Chemical Treated HepG2 cells. Southeast Regional Lipid Conference, Georgia, USA, 2003.

 

Mechanism of Serine Palmitoyltransferase-1 Attenuation of Cytochrome P450 1A1 Expression. Tenth International RCMI Symposium, Maui, Hawaii, 2001.

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