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Clinical Research Coordinator - Phase I studies Resume Example

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CLINICAL RESEARCH COORDINATOR - PHASE I STUDIES
Summary

Industrious, performance-driven health care professional with over 10 years of experience and an established track record of achievement. Excellent interpersonal skills and a demonstrated ability to work with people from all levels within and beyond the organization.

Highlights
  • Good written and verbal communication
  • Bilingual (Engligh/Spanish)
  • Instruction and training
  • Team coordination
  • Conflict resolution
Experience
University of Miami School of Medicine / Sylvester COmprehensive Cancer CenterMiami, FLClinical Research Coordinator - Phase I studies01/2014 to 02/2015

Effective study coordinator for Phase I oncology studies, able to coordinate multiple clinical trials simultaneously:

  • Preparation of all clinical study budget financial analyses, including analysis of budget/forecast variances, ensuring they are prepared effectively and in a concise and understandable manner
  • Development of operational processes to support financial aspects of clinical studies
  • Maintain effective and ongoing communication with research participants, sponsors, nurses and investigators during the course of the study.
  • Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics. Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Instruct research staff in scientific and procedural aspects of studies
  • Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
  • Schedule subjects for appointments and procedures as required by study protocols.
  • Research and analyze information to determine appropriate course of action. Follow up with internal personnel and sponsoring companies regarding outstanding issues.
  • Manage daily billing functions for clinical trials.
  • Use Medicare Coverage Analysis to determine the eligibility of studies related tests.
  • Participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
  • Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Memorial Healthcare System – Memorial Cancer Institute Office of Human ResearchHollywood, FLClinical Coordinator II03/2012 to 01/2014
  • Liaison between Principal Investigators, Research Nurses and Sponsor and or CRO
  • Assist in numerous clinical studies to include all facets of documentation
  • Assure protocol compliance maintaining study time lines
  • Collects data as required by the protocol. Responsible for timely completion of Case Report Forms, ensuring accuracy and consistency of research data between electronic source documents and data entries (CRF/eCRF)
  • Responsible for the organization of Cooperative Groups sponsored trials, including coordination of SIVs, creation of training materials and warranting availability of kits and subject tools.
  • Assists Principal Investigator to assure that all key personnel or persons “engaged” in the research project have met training requirements in accordance with Federal regulations and Institution and sponsoring agency policies and procedures.
  • Collaborates with the Principal Investigator, Research Nurses and research staff in the preparation and respond to any study related audits.
  • Liaison between Principal Investigators and Regulatory agencies for the regulatory submission and maintenance of oncology clinical studies and INDs.
  • Maintains effective and ongoing communication with research participants, research nurse and study investigators during the course of the study.


University of Miami - Sylvester Comprehensive Cancer CenterMiami , FLSenior Regulatory Analyst 04/2004 to 03/2012
  • Liaison between Principal Investigators and Regulatory agencies (University of Miami Institutional Review Board, CIRB, and Western Institutional Review Board) for the submission and maintenance of oncology trials.
  • IND submission to the Food and Drug Administration for Sponsor-Investigator studies, as well as treatment and emergency use studies. Maintenance and closure of INDs.
  • Assist in the development of clinical protocols and Informed Consent Forms for investigator initiated studies prior to submission to the regulatory agencies.
  • Support to the regulatory team and clinical research coordinators to ensure compliance with local policies and federal regulations.
  • Active role in the preparation for FDA, industry and Institutional QA audits. Assisting auditors during their visits and responding audit reports.
  • Maintains study time lines
  • Training, mentoring and overseeing of junior Regulatory Analysts.
  • Creation and update of policies and procedures.
Banco Popular de Ahorro / Corporate Offices Ciudad de la Habana, CubaManager - Financial Risk Analysis Department02/1996 to 09/2003
  • Examining firms' investment portfolios to analyze risk associated with financial decisions.
  • Identify, research and highlight investment approaches, including allocation of assets and fixed income.
  • Maintain and analyze loan portfolio. Prepared monthly portfolio reports for presentation to management.
  • Process loan documents and loan account transactions, as well as reconcile loan related accounts for accuracy.
  • Ensure compliance with accounting deadlines. Prepared loan accounts for audits
  • Provide internal and external auditing services for businesses.
  • Maintain good client relations.
Education
BBA:Accounting2011School of Business Administration - University of Miami, Miami, FL, United States
Accounting and Finances2002School of Business Administration - Universidad de la Habana, Ciudad de la Habana, Cuba
Pharmaceutical Sciences1994School of Pharmaceutical Sciences - Universidad de la Habana, Ciudad de la Habana, Cuba
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Resume Overview

Companies Worked For:

  • University of Miami School of Medicine / Sylvester COmprehensive Cancer Center
  • Memorial Healthcare System – Memorial Cancer Institute Office of Human Research
  • University of Miami - Sylvester Comprehensive Cancer Center
  • Banco Popular de Ahorro / Corporate Offices

School Attended

  • School of Business Administration - University of Miami
  • School of Business Administration - Universidad de la Habana
  • School of Pharmaceutical Sciences - Universidad de la Habana

Job Titles Held:

  • Clinical Research Coordinator - Phase I studies
  • Clinical Coordinator II
  • Senior Regulatory Analyst
  • Manager - Financial Risk Analysis Department

Degrees

  • BBA : Accounting 2011
    Accounting and Finances 2002
    Pharmaceutical Sciences 1994

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