Project Clinical Research

Jose Miguel Arriaga, MS, CCRP

Work Address

The University of Texas MD Anderson Cancer Center

**** ******** *********

Houston, Texas 77030-4009

Work Phone 713-***-****

************@*******.***

Cell Phone 281-***-****

Education & Professional Affiliations

SoCRA & ACRP member

• Certified as a Clinical Research Professional by the Society of Clinical Research Associates (SoCRA) in September 2010.

• Obtained 17 credit contact hours at the ACRP 2012 Global Conference in April 2012

Master of Science in Veterinary Microbiology at Texas A&M University

Graduation date August 2002

Bachelor of Science in Genetics at Texas A&M University

Graduation date August 1996

Clinical Research Experience

As an IND Coordinator,

• Provide support and coordinate regulatory activities for MDACC IND studies to ensure regulatory compliance with federal agencies.

• Liaison between the principal investigator and the FDA for submissions of IND/IDE annual reports, and other correspondence to and from FDA, and maintain documentation of these communications.

• Responsible for the notification, collection, and submission of all Protocol Specific IND/IDE Annual Reports which involves continuous interaction with principal investigators and education of the research teams to ensure that all information is current and accurate and in compliance with regulatory requirements.

• Conduct internal audits to ensure the IND files are complete and accurate, to identify areas of inconsistency between different project managers and to track indicators that help the IND office improve quality of current and future regulatory procedures.

As a Clinical Study Coordinator (CSC)

• Responsible for the management and conduct of numerous aspects of on-going clinical studies adhering to the human protection regulatory requirements stipulated in the ICH Guideline of Good Clinical Practices and Code of Federal Regulations.

• Conducted the screening and consenting process of patients for clinical protocols within the Stem Cell Transplant & Cellular Therapy (SCT & CT) department at MD Anderson Cancer Center.

• Assisted in the accurate collection and analysis of follow up data, as well as compliance of Serious Adverse Event information in a timely matter.

• Assisted investigators in the compilation and maintenance of regulatory binders following guidelines of the good clinical practices.

• Use the protocol as a tool that describes the objective(s), design, and methodology to conduct all aspect of the clinical trial and the document that explains the rationale for the implementation of the study.

Teaching and Research Experience

As an Adjunct Faculty

• Nine years of experience teaching college-level human anatomy and physiology, microbiology, biotechnology, and general biology.

• Demonstrated efficiency at researching and presenting large amounts of information to a diverse audience.

As a Senior Research Associate

• Responsible of initiating and managing numerous projects. Each project involved an extensive analysis, use database research and organization. Additionally, projects were managed through several stages, ultimately leading to completion of the project and analysis of the completed results.

• Gained extensive knowledge of numerous molecular biological tools and databases.

• Demonstrated my ability to effectively manage and organize large amounts of data.

• Participated in company-wide programs to consolidate and analyze experimental data from mouse models. Program helped develop an understanding of the drug-developmental process and encourages participation in identifying promising drug targets.

As a Research Assistant and Graduate Student

• Developed my knowledge and understanding of biology and the scientific process, and the ability to organize and present scientific data.

• Compiled my research results and presented them at laboratory meetings composed of 12 laboratory members including the principal investigators.

• Participated in journal club presentations and discussions.

Awards and Publications

Arriaga J. M., Cohen N. D., Derr J. N., Chaffin M. K. Martens R. J. 2002. Detection of Rhodococcus equi by polymerase chain reaction using species-specific nonproprietary primers. J Vet Diagn Invest 14:347-353.

Winner of the Department of Biology undergraduate poster session in December 1995: Isolation of two putative tryptophan decarboxylase (TDC) genomic clones from alkaloid producing species Camtotheca acuminata.

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