I am a Certified Clinical Research Professional with 5 years of experience in working with local and central IRB's, Contract Research Organizations, Universities, and pharmaceutical industry leaders, in efforts to both acquire and maintain approval to conduct research.
Guiding research community members, communicating detailed information professionally and with brevity, both orally and in writing.
Creating education documents and presenting educational sessions to demonstrate research approval requirements for biomedical, social, and behavioral research.
Extrapolating requirements from regulations and SOP's to provide guidance for the research community.
Work efficiently within deadline requirements and in high-pressure environments.
Use and provide assistance in use of Clinical Trial Management Systems (CTMS) and electronic IRB applications.
05/2013 to Current
IRB COORDINATORThe University of Texas Health Science Center at Houston – Houston, TX
Certify that all aspects of a study design pertaining to the protection of human subjects, such as; recruitment, consent process, study procedures, and handling Protected Health Information, are clearly established within the study protocol and IRB application; and are in compliance with applicable regulations and institutional guidelines prior to IRB approval.
Ensure that all required documents for IRB approval of a research study are received for review, such as; FDA or Sponsor letters regarding IND or IDE, an adequately written Protocol, IRB approval or letters of support from collaborating entities, Investigator's Brochure, Investigational device descriptions, Informed consents, data collection forms, CV's, and GCP training verification.
Review coverage analysis reports and spreadsheets to ascertain billable and non-billable research procedures to clarify possible costs to research subjects Provide guidance and support to principle investigators and/or study coordinators in resolving IRB contingent approvals.
Prepare and/or revise informed consent documents, study recruitment materials, CRF/Data Collection forms, and subject materials as needed.
Assist in periodic review and revision of IRB department SOPs to ensure accuracy with current FDA, OHRP, AAHRPP, and Institutional guidelines.
Facilitate IRB meeting time, location, and member accommodations.
Prepare and distribute IRB meeting agendas and minutes.
07/2012 to 01/2013
STUDY START-UP SPECIALIST (contract)Research Pharmaceutical Services (RPS) – now PRA Health Sciences – Fort Worth, TX
Managed all regulatory documents (such as; 1572's, Statement of Investigator, CVs, and Financial Disclosures) for all clinical sites within my assigned U.S.
Reviewed Monitoring reports from study initiation, follow-up and close-out visits for accuracy and entry into CTMS and TMF.
Interacted with central and local IRBs to submit study renewals and amendments and to resolve discrepancies preventing IRB approval.
Assisted clinical sites with maintaining up to date study approval status and currently approved study documents.
Archived documents into the Trial Master File and conducted periodic audits to ensure accuracy of documents and to collect missing documents.
Monitored status of budgets and contracts, investigational product distribution, and other site readiness needs prior to initiating site access to begin study participation.
05/2010 to 07/2012
SENIOR PROJECT SPECIALIST - IRBMcKesson Specialty Health – The Woodlands, TX
Conducted preliminary reviews of protocol submissions, ensuring compliance with SOPs, federal regulations, and applicable state regulations.
Assisted in decreasing barriers to study approval times by collaborating with Regulatory Affairs to provide education of IRB approval requirements, clarify regulatory department needs, and streamlining document submission processes, both to and from the IRB.
Assisted IRB Manager in writing, developing and implementing SOP's and training manual for the IRB and Safety team.
Collaborated with Quality Assurance team to create corrective action plans for serious non-compliant clinic sites.
Maintained IRB member files (financial disclosures, conflict of interest, confidentiality agreements, indemnification agreements, continued education, and CVs).
Created spreadsheets to document billable IRB actions and compensation for IRB members.
Compiled participating site data to create and distribute the IRB Annual report and Community Profile.
Evaluated reports of unanticipated problems, deviations, and adverse events; and prepared informative reports of safety activity to IRB members for review.
Communicated with local IRBs to establish Cooperative review agreements.
Distributed weekly reports of IRB actions and approvals to Network.
Trained IRB coordinators and new committee members on company policies, FDA, and OHRP regulations.
Certified Clinical Research Professional (CCRP) – via The Society of Clinical Research Associates,
Inc. (SOCRA) – expires August 2018
BBA: International Business and Finance University of Houston-Downtown - Houston, TX