Clinical Research Professional

G. Rene Contreras

**** ***** *** • San Antonio, TX 78240 • email: ******@*******.*** • phone: 210-***-****

OBJECTIVE: To utilize skills obtained as a clinical research professional, in a professional company with opportunities for growth and continued education.

EXPERIENCE: 09/2007 – Present CEDRA Clinical Research, LLC San Antonio, TX

Study Conduct Manager

Served as a direct supervisor of Coordinating staff. Involved in protocol review, logistical planning, and determining feasibility of clinical trials. Also involved in recruitment and training of staff. Participated in review of SOPs, DOPS, and training materials. Assisted Quality Assurance unit in conducting site audits to determine site eligibility for specialized trials. Conducted meetings with study team to ensure critical deadlines are met, and that all final products exceeded client expectations.

11/2005 – 08/2007 CEDRA Clinical Research, LLC San Antonio, TX

Clinical Research Coordinator

Involved in all stages of conducting a clinical trial from initiation of the protocol, until study closeout. Review of protocol, amendments and administrative letters. Review and edit of case report form template, informed consent, and source documents. Sets up and maintains regulatory documents according to established SOP guidelines. Completion of FDA data tables, and review and edit of clinic final report according to GCP/ICH guidelines. Coordinates meetings with study personnel to plan recruitment, scheduling, and logistics of study. Communicates with Project Manager, and Investigator, to update on study progress. Involved in attending meetings with Sponsors, and completion of DCFs, and correspondence of essential study documents.

09/2005 – 11/2005 CEDRA Clinical Research, LLC San Antonio, TX

Assistant Clinical Research Coordinator

Primarily involved in supporting Study Coordinator with conduct of clinical trial. Responsible for entry of data in to both paper and electronic case report forms. Review and edit of case report form template, and source documents. Assist with administrative support, preparation of study materials, payment requests, and assists as a liaison with study subjects. Communicates with Study Coordinator, and other study personnel.

07/2005 – 09/2005 South Texas Blood & Tissue Center San Antonio, TX

Processing Lab Technician

Daily activities include processing and testing of plasma and whole blood samples. Samples are analyzed for HIV, Hepatitis B surface antigen, Hepatitis C, liver enzymes, and blood type. Validation of the reagents to be used for testing, according to GLP and SOP guidelines. Review of testing theory and mechanics. Communicates with lab supervisor or testing progress.

10/2004 – 06/2005 Diabetes & Glandular Disease San Antonio, TX

Research Associates

Laboratory Studies Coordinator

Coordinating of device studies. Main focus, Diabetes Mellitus. Duties include maintaining accurate source documents and CRFS. Recruiting patients from a well maintained database. Consenting patients according to SOPs and GCP/ICH guidelines, and performing procedures according to study protocol. Developing protocol, CRFs, and data input. Maintain stock and accountability of investigational material, keeping Primary Investigator updated of study progress.

EDUCATION: 8/2004 University of Texas- San Antonio US-TX-San Antonio

Bachelors Degree

Bachelors of Science in Biology

Bachelors of Arts in Psychology

REFERENCES: Available upon request

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